Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405874828622 Date of Registration: 14/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Combined Anodal tDCS over M1 and F3 Regions in Diabetic Neuropathic Pain: Double-blind Randomized Controlled Study.
Official scientific title Efficacy of Combined Anodal tDCS over M1 and F3 Regions in Diabetic Neuropathic Pain: Double-blind Randomized Controlled Study.
Brief summary describing the background and objectives of the trial Type 2 diabetes is defined as a metabolic disorder characterized by high blood glucose levels caused by insufficient insulin production by the pancreas. Neuropathic pain (NP) is pain that caused by damage to the central or peripheral nervous system or both which has a significant negative impact on the quality of life. Diabetic neuropathic pain (DNP) is characterized by a burning sensation, tingling, severe pain, shooting and cutting sensations, or even a feeling of electric shock, and it frequently disrupts the affected person’s sleep and routine activities. Although there are several therapeutic options for treating NP, it is still refractory to medical treatment in 60%. Therefore, DPN has posted a great challenge. Transcranial direct current stimulation (tDCS), an application of electrical currents to modify brain function. tDCS is a safe noninvasive technique in which a low amplitude electrical current is conducted to the cortex via scalp electrodes. The systemic immune-inflammation index (SII), an integrated and novel inflammatory biomarker integrating three different cells and was calculated as the platelet count × neutrophil count/lymphocyte count which could better reflect the state of inflammation and immune balance in the body . objectives of trial To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. To investigate the possible effect of anodal transcranial direct current stimulation (tDCS) on the systemic immune-inflammatory index. To investigate the effect of combined anodal transcranial direct current stimulation on the hospital anxiety and depression scale.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/05/2024
Actual trial start date 30/05/2024
Anticipated date of last follow up 30/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group 2 Sham Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week). Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. 20 Placebo
Experimental Group Group 1 Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere Participants will attend 10 sessions of the relevant intervention (5 sessions per week). Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. 10
Experimental Group Group 1 tDCS Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere Participants will attend 10 sessions of the relevant intervention (5 sessions per week). Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. 20
Control Group Group 2 Sham Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week). Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. 20 Placebo
Experimental Group Group 1 tDCS Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere Participants will attend 10 sessions of the relevant intervention (5 sessions per week). Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Type 2 diabetic patients according to the 1999 World Health Organization (WHO) diagnostic criteria Type-2 diabetes and neuropathic pain, at least 5 years of diabetes history • Aged 45 to 65 years, • Ability and willingness to participate in intervention sessions. • Use of strong painkillers • Medical conditions causing NP as herniated disc or stroke • History of head or neck surgery. • Use of a cardiac pacemaker or defibrillator • Subjects with diabetic foot ulcers and amputation • Absence in more than two sessions or more than four days between sessions Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/04/2024 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
56 Ramsis St., Abbasseya, Cairo Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. Before and after the end of sessions 10 days and follow up after 2 months
Secondary Outcome 1- To investigate the possible effect of anodal transcranial direct current stimulation (tDCS) on the systemic immune-inflammatory index. 2- To investigate the effect of combined anodal transcranial direct current stimulation on the hospital anxiety and depression scale. Before and after the end of 10 sessions and follow up of 2 months
Primary Outcome To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. Before and after the end of sessions 10 days and follow up after 2 months
Secondary Outcome 1- To investigate the possible effect of anodal transcranial direct current stimulation (tDCS) on the systemic immune-inflammatory index. 2- To investigate the effect of combined anodal transcranial direct current stimulation on the hospital anxiety and depression scale. Before and after the end of 10 sessions and follow up of 2 months
Primary Outcome To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. Before and after the end of sessions 10 days and follow up after 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ain Shams Faculty of medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt
University of Ain Shams Faculty of medicine 56 Ramsis St., Abbasseya Cairo 11799 Egypt
University of Ain Shams Faculty of medicine 56 Ramsis St., Abbasseya Cairo 11799 Egypt
University of Ain Shams Faculty of medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mary Atef Nassif Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt. Cairo 11566 Egypt
Ain Shams University Hospitals El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt. Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Faculty of Medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt University
Primary Sponsor Ain Shams University Faculty of Medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Omnia Ali Abubakr 56 Ramsis St., Abbasseya Cairo 11566 Egypt
Omnia Ali Abubakr 56 Ramsis St., Abbasseya Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omnia Ali Abubakr omnia_bakr@med.asu.edu.eg 01030242593 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Physical Medicine Rheumatology and Rehabilitation
Role Name Email Phone Street address
Public Enquiries Mary Atef Nassif yan_rheum@med.asu.edu.eg 01006135348 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Physical Medicine Rheumatology and Rehabilitation
Role Name Email Phone Street address
Scientific Enquiries Mary Atef Nassif yan_rheum@med.asu.edu.eg 01006135348 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Physical Medicine Rheumatology and Rehabilitation
Role Name Email Phone Street address
Scientific Enquiries Mary Atef Nassif yan_rheum@med.asu.edu.eg 01006135348 Misr El Gedida
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Physical Medicine Rheumatology and Rehabilitation
Role Name Email Phone Street address
Principal Investigator Omnia Ali Abubakr omnia_bakr@med.asu.edu.eg 01030242593 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Rheumatology Rehabilitation and Physical Medicine
Role Name Email Phone Street address
Public Enquiries Mary Atef Nassif yan_rheum@med.asu.edu.eg 01006135348 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Rheumatology Rehabilitation and Physical Medicine
Role Name Email Phone Street address
Scientific Enquiries Omnia Ali Abubakr omnia_bakr@med.asu.edu.eg 01030242593 El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of Rheumatology Rehabilitation and Physical Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de identification (text, tables, and figure) Informed Consent Form,Study Protocol Immediately following publication. No end date. Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://docs.google.com/document/d/131I4VyAaUb5rkJjwHbkFY4XnKEB-d-k5/edit?usp=sharing&ouid=105131762347206704633&rtpof=true&sd=true Yes 19/12/2024 28/01/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/12/2024 Result - 28/02/2025 Result - 19/12/2024 Result - 19/12/2024 Result - 19/12/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://docs.google.com/document/d/131I4VyAaUb5rkJjwHbkFY4XnKEB-d-k5/edit?usp=drive_link&ouid=105131762347206704633&rtpof=true&sd=true
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 05/11/2024 Use of transcranial direct current stimulation (tDCS) Rehabilitation Treatment: Devices
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 24/01/2025 PACTR Admin 30 May 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 05/11/2024 Number of patients increased to increase the accuracy of results 40
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 16/10/2024 Patients were recruited since 30 May 2024 Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 08/05/2025 Recruitment was completed since 30 November 2024 Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 16/10/2024 More suitable for allocation Sealed opaque envelopes Numbered containers
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 16/10/2024 More suitable Numbered containers Sealed opaque envelopes
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 16/10/2024 More suitable for allocation Sealed opaque envelopes Numbered containers
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 05/11/2024 More suitable Numbered containers Sealed opaque envelopes
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 16/10/2024 According to who definition of DM • Type-2 diabetes and neuropathic pain, at least 5 years of diabetes history • Aged 45 to 65 years, • Ability and willingness to participate in intervention sessions. • Type 2 diabetic patients according to the 1999 World Health Organization (WHO) diagnostic criteria Type-2 diabetes and neuropathic pain, at least 5 years of diabetes history • Aged 45 to 65 years, • Ability and willingness to participate in intervention sessions.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 05/11/2024 To increase the accuracy of patients selection • Use of strong painkillers • Not suffering from any medical conditions (such as a herniated disc, or injuries from a serious accident that took place within the previous three months) that induce neuropathic and chronic pain • History of head or neck surgery. • Use of a cardiac pacemaker or defibrillator • Subjects with diabetic foot ulcers and amputation were excluded from the study. Diabetic subjects with stroke. • Absence in more than two sessions or more than four days between sessions • Use of strong painkillers • Medical conditions causing NP as herniated disc or stroke • History of head or neck surgery. • Use of a cardiac pacemaker or defibrillator • Subjects with diabetic foot ulcers and amputation • Absence in more than two sessions or more than four days between sessions
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 09/05/2025 PACTR Admin Middle Aged: 45 Year(s)-64 Year(s) Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 16/10/2024 Study on neuropathy due to diabetes Nervous System Diseases, Nutritional, Metabolic, Endocrine Nervous System Diseases
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 05/11/2024 To increase the accuracy of results Care giver/Provider, Participants Outcome Assessors, Care giver/Provider, Participants
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/11/2024 To increase the accuracy of results Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Control Group, Group 2, Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere., Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Control Group, Group 2, Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/10/2024 recruited more participants Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/11/2024 To increase the accuracy of results Control Group, Group 2, Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/05/2025 Clarify intervention name Control Group, Group 2 , Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere , Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week). , Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. , 10, Placebo Control Group, Group 2 Sham, Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere , Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week). , Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. , 10, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/05/2025 Clarify intervention name, actual number of participants Control Group, Group 2 Sham, Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere , Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week). , Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. , 10, Placebo Control Group, Group 2 Sham, Patients will receive medical treatment and sham tDCS over the same areas. The electrodes will be places over the same areas as in group 1 but without any stimulation. Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere , Participants in each group will attend 10 sessions of the relevant intervention (5 sessions per week). , Patients will receive medical treatment and will have sham tDCS over the same areas of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index. , 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/05/2025 Clarify intervention name Experimental Group, Group 1, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20, Experimental Group, Group 1 tDCS, Treatment time is 10 minutes right M1, 10 minutes over left M1 and 20 minutes over F3. Current intensity will be adjusted to 2 (mA) milliampere, Participants will attend 10 sessions of the relevant intervention (5 sessions per week)., Patients will receive medical treatment and will have tDCS of both the primary motor cortex (M1), and dorsolateral prefrontal cortex (DLPFC) (F3). They will be also reexamined in terms of perceived pain intensity, hospital anxiety and depression scale, systemic immune-inflammatory index immediately after the intervention (as the posttest). Follow up at two months after the end of intervention: Patients will be assessed by SF-MPQ-2, hospital anxiety and depression scale and SII index., 20,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 more precise parameters Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) 10 minutes right M1, 10 minutes over left M1 and left dorsolateral prefrontal cortex (F3) regions and 20 minutes over F3 measured by McGill Pain questionnaire., Before as a pre-test and after the end of sessions 10 days as a post-test and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 more precise parameters Primary Outcome, To investigate the diabetic neuropathic pain measured by McGill Pain questionnaire before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) 10 minutes right M1, 10 minutes over left M1 and left dorsolateral prefrontal cortex (F3) for 20 minutes over F3regions measured by McGill Pain questionnaire., Before and after the end of sessions 10 days and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 Assess severity of pain Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) treated for 10 minutes right M1 and 10 minutes over left M1 and left dorsolateral prefrontal cortex (F3) regions for 20 minutes measured by McGill Pain questionnaire and by visual analogue scale (VAS), Before and after the end of sessions 10 days and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 Assess severity of pain Primary Outcome, o investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire and visual analogue scale vas, Before and after the end of sessions 10 days and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 Assess severity of pain Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. Visual analogue scale of pain, Before and after the end of sessions 10 days and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 Assess severity of pain Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. Assess pain severity by visual analogue scale VAS , Before and after the end of 10 sessions and follow up of 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/10/2024 Assess severity of pain Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire. Use of visual analogue scale VAS, Before and after the end of 10 sessions and follow up of 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 05/11/2024 No change Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire., Before and after the end of sessions 10 days and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 05/11/2024 No change Secondary Outcome, 1- To investigate the possible effect of anodal transcranial direct current stimulation (tDCS) on the systemic immune-inflammatory index. 2- To investigate the effect of combined anodal transcranial direct current stimulation on the hospital anxiety and depression scale., Before and after the end of 10 sessions and follow up of 2 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 28/02/2025 No change Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire., Bdfore and after the end of sessions 10 days and follow up after 2 months Primary Outcome, To investigate the diabetic neuropathic pain before and after treatment with combined anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions measured by McGill Pain questionnaire., Before and after the end of sessions 10 days and follow up after 2 months
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 16/10/2024 More suitable University of Ain Shams Faculty of medicine, 56 Ramsis St., Abbasseya, Cairo, 11799, Egypt
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 16/10/2024 More suitable postal code University of Ain Shams Faculty of medicine, 56 Ramsis St., Abbasseya, Cairo, 11799, Egypt
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 05/11/2024 No Change University of Ain Shams Faculty of medicine, 56 Ramsis St., Abbasseya, Cairo, 11566, Egypt
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 05/11/2024 Ain Shams University funded the trial Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt., Cairo, 11566, Egypt, University,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 05/11/2024 No change Ain Shams University Faculty of Medicine, 56 Ramsis St., Abbasseya, Cairo, 11566, Egypt, Primary Sponsor, University,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 05/11/2024 No change Omnia Ali Abubakr, 56 Ramsis St., Abbasseya, Cairo, 11566, Egypt
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 16/10/2024 Change street address Scientific Enquiries, Mary, Atef Nassif, Dr., yan_rheum@med.asu.edu.eg, , 01006135348, Misr El Gedida, Cairo, 11566, Egypt, Lecturer of Physical Medicine Rheumatology and Rehabilitation
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 05/11/2024 No change Principal Investigator, Omnia, Ali Abubakr, Dr., omnia_bakr@med.asu.edu.eg, , 01030242593, Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt., Cairo, 11566, Egypt, Lecturer of Rheumatology Rehabilitation and Physical Medicine
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 05/11/2024 No change Public Enquiries, Mary , Atef Nassif, Dr., yan_rheum@med.asu.edu.eg, , 01006135348, Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, 11566, Egypt, Lecturer of Rheumatology Rehabilitation and Physical Medicine
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 05/11/2024 No change Scientific Enquiries, Omnia, Ali Abubakr, Dr., omnia_bakr@med.asu.edu.eg, , 01030242593, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt., Cairo, 11566, Egypt, Lecturer of Rheumatology Rehabilitation and Physical Medicine
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 28/01/2025 Not yet sent for publication 28 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 19/12/2024 This is the first results available https://drive.google.com/file/d/1_DF1AaCcLHaOGNzIijiDImKvU3DxVGhP/view?usp=sharing
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 16/10/2024 New link for protocol https://docs.google.com/document/d/131I4VyAaUb5rkJjwHbkFY4XnKEB-d-k5/edit?usp=sharing&ouid=105131762347206704633&rtpof=true&sd=true
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 19/12/2024 No change in protocol https://docs.google.com/document/d/131I4VyAaUb5rkJjwHbkFY4XnKEB-d-k5/edit?usp=drive_link&ouid=105131762347206704633&rtpof=true&sd=true
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 05/11/2024 To be in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki) Study Protocol Study Protocol, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 19/12/2024 Results now are available No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 19/12/2024 Results now are available 30490_21112_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 2 19/12/2024 No change in results 30490_21112_1046.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 2 28/02/2025 second drafted results 30490_21112_1046.pdf 30490_21112_1046.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 3 19/12/2024 No change in results 30490_21112_1047.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 4 19/12/2024 No change in results 30490_21112_1048.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 5 19/12/2024 No change in results 30490_21112_1049.pdf