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.: PACTR202310887998176 Date of Approval: 10/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An EEG study of chronic post stroke aphasia patients
Official scientific title An EEG study of chronic post stroke aphasia patients
Brief summary describing the background and objectives of the trial EEG is a reliable technique for exploring functional activity of the brain and is sensitive to changes in neural plasticity processes and clinical recovery after brain lesion. Transcranial direct current stimulation (tDCS) is a promising non-invasive method of neuromodulation, which works by inducing electrical current flow to the scalp by means of 2 electrodes, for usually up to 10 to 30 min. Based on multiple clinical studies, tDCS has had positive effects on post-stroke aphasia rehabilitation in humans. our objectives are to study resting state EEG in cases of chronic post stroke aphasia, and To identify if tDCS can cause changes in the resting state EEG of those patients and if these changes correlate with outcome assessed by aphasia rating scales.
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 01/10/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date 01/09/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Resting state EEG before and after recieving active sessions of tDCs 6 sessions active tDCS assessed by resting state EEG and western aphasia battery scale before and after sessions 2 weeks for each patients 1. EEG protocol: Resting state EEG will be done for 6 minutes (3 minutes with eyes open and 3 minutes with eyes closed) for the study groups at baseline and for the members of the age matched healthy control group. It will be repeated only for members of the study group after the last tDCS session. 2. tDCS protocol: patients will be randomly allocated to 2 groups: All patients will perform a 3-dimensional magnetic resonance imaging (3D MRI) brain; an MRI brain with T1WI done with 200 cuts of 0.9 mm sections used to create a 3D virtual head model for each patient. The head model was then segmented to separate the scalp, skull and brain layers. 4 perilesional (along outer border of the lesion) stimulation targets using a neuronavigation system ANT (visor 2). Dots will be used to mark the 4 perilesional areas on a patient's skin with a permanent marker to be used as guide at each of tDCS sessions. Patients will be randomly allocated to 2 groups: online randomization http://www.graphpad.com/quickcalcs/index.cfm. 3.Western aphasia battery revised will be performed for the study group 4 times for each patient (before starting both active and sham tDCS sessions and after both last active and last sham tDCS session), so as to detect aphasia type, severity, its outcome after the sessions. 4.Stroke Aphasia Depression Questionnaire 10 (Sutcliffe LM., et al, 1998) will be applied to detect accompanying depression and if it changed after sessions. 40
Control Group EEG resting state and western aphasia battery 6 sessions sham tDCS assessed by resting state EEG and western aphasia battery scale before and after recieving sessions 2 weeks for each patient 1.Resting state EEG will be done for 6 minutes (3 minutes with eyes open and 3 minutes with eyes closed) for the study groups at baseline and for the members of the age matched healthy control group 2.tDCS protocol: patients will be randomly allocated to 2 groups: All patients will perform a 3-dimensional magnetic resonance imaging (3D MRI) brain; an MRI brain with T1WI done with 200 cuts of 0.9 mm sections used to create a 3D virtual head model for each patient. The head model was then segmented to separate the scalp, skull and brain layers. 4 perilesional (along outer border of the lesion) stimulation targets using a neuronavigation system ANT (visor 2). Dots will be used to mark the 4 perilesional areas on a patient's skin with a permanent marker to be used as guide at each of tDCS sessions. 3.Western aphasia battery revised will be performed for the study group 4 times for each patient (before starting both active and sham tDCS sessions and after both last active and last sham tDCS session), so as to detect aphasia type, severity, its outcome after the sessions. 4.Stroke Aphasia Depression Questionnaire 10 (Sutcliffe LM., et al, 1998) will be applied to detect accompanying depression and if it changed after sessions. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age over 18 years. 2. Patients presenting with first ever ischemic stroke causing aphasia expressive or receptive or mixed 3. A duration of 3 months to 1 year from onset of stroke. 1. Previous ischemic stroke or hemorrhagic stroke. 2. Contraindications to tDCS as: a history of epilepsy, intracranial surgeries, skull defects or pregnant females. 3. Scoring 14 or more out of 30 in Stroke Aphasia Depression Questionnaire 10. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 17/11/2022 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque, Cairo Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 2. Explore the potential correlations between baseline resting state EEG in aphasic patients and structural brain lesions observed in MRI scans and baseline clinical skills. 2 weeks
Primary Outcome 1. tDCS can be used to treat chronic post stroke aphasia and causes changes in resting state EEG. 2 weeks after recieving of tDCS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neurology clinics in Ain Shams University hospitals 38 Abbassia, Next to the Al-Nour Mosque, Cairo Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 38 Abbassia, Next to the Al-Nour Mosque, Cairo Cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fatma Fatahallah Kenawy 38 Abbassia, Next to the Al-Nour Mosque, Cairo Cairo 1181 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nevine Medhat EL Nahas nevine_elnahas@med.asu.edu.eg +201227910517 38 Abbassia, Next to the Al-Nour Mosque, Cairo
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Head of Neuropsychiatry department Ain Shams university hospitals
Role Name Email Phone Street address
Scientific Enquiries Nourhan Belal Atef Mohammed nourhan.belal@med.asu.edu.eg 01092008719 38 Abbassia, Next to the Al-Nour Mosque, Cairo
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Assisstant lecturer of Neurology Ain Shams university hospitals
Role Name Email Phone Street address
Public Enquiries Hussein Hammouda Hassan Dochusseinsharaf@gmail.com 01067035930 38 Abbassia, Next to the Al-Nour Mosque, Cairo
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Assisstant lecturer of Neurology Ain Shams university hospitals
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 deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication Controlled access for PI, coPI, editors and reviewers assigned by journal of submission Type of data analysis permitted: no data analysis permitted Requesting data: from PI and co PI Reviewing requests: specialized neurologists
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information