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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202608496298337 Date of Registration: 07/08/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Serum Neurofilament Light Chain (sNfL) and its correlation to Cognitive function in Multiple Sclerosis
Official scientific title Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Serum Neurofilament Light Chain (sNfL) and its correlation to Cognitive function in Multiple Sclerosis
Brief summary describing the background and objectives of the trial Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulatory technique that has emerged as a promising therapeutic intervention for various neurological disorders by modulating cortical excitability and neural plasticity. Multiple sclerosis (MS) is a chronic inflammatory demyelinating condition marked by central nervous system (CNS) lesions that can cause significant physical or cognitive disability, as well as neurological abnormalities. We now know that 40-70% of all MS patients have cognitive impairment that impairs their lives. Even in these so-called benign forms of the disease, 15 years after diagnosis, with an Expanded Disability Status Scale (EDSS) score of up to 3, cognitive abnormalities can be diagnosed in half of these patients. To investigate whether high frequency (rTMS) can modify MS cognition assessed by clinical and serum Neurofilament Light Chain (sNfL).
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 20/05/2022
Actual trial start date 20/05/2022
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date 01/08/2024
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group High frequency rTMS on the left dorsolateral prefrontal cortex 18 Hz, 120% of resting motor threshold, 30 trains, 1800 pulses per session Daily for 10 sessions over two consecutive weeks High-frequency rTMS applied over the left dorsolateral prefrontal cortex (Lt. DLPFC) 15
Experimental Group rTMS over the vertex 5 Hz, 110% of resting motor threshold, 900 pulses per session Daily for 10 sessions over two consecutive weeks rTMS applied over the vertex as an active control site 15
Control Group Sham stimulation Identical parameters to active groups, but with the coil positioned perpendicular to the scalp Daily for 10 sessions over two consecutive weeks Sham stimulation designed to replicate auditory and sensory experiences without effective cortical stimulation 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the 2017 updated McDonald criteria. Adults of both sexes. Clinically stable disease. Expanded Disability Status Scale (EDSS) scores between 2 and 5. Free from relapse for the last three months. No treatment with corticosteroids within 30 days before enrollment. Stable disease-modifying therapy for at least three months before inclusion (when applicable). Effective contraception for women capable of delivering children. Reported subjective cognitive complaints during routine neurological assessment. History of serious psychiatric illness. Substance misuse. Pregnancy. Implanted electronic or ferromagnetic devices. Presence of other neurological illnesses. Significant systemic comorbidities. Lack of compliance or refusal to provide informed consent. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 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 17/05/2022 Institutional Review Board IRB Faculty of Medicine Al Azhar University Assiut
Ethics Committee Address
Street address City Postal code Country
El Walideya El Bahareya, Qism Thani Asyut Assiut 2091110 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cognitive performance assessed using the Brief International Cognitive Assessment for Multiple Sclerosis BICAMS Baseline, immediately after completion of the 10-session rTMS intervention, and at the 3-month follow-up
Secondary Outcome Serum neurofilament light chain (sNfL) levels Baseline, immediately after completion of the 10-session rTMS intervention, and at the 3-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Neurology Al Azhar University Hospital El Walideya El Bahareya, Qism Thani Asyut Asyut Egypt
Assiut Health Insurance Hospital El Hamra El Thania, El Fath Asyut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Yassin Hassan Al-Azhar Street, Asmaa Allah Al-Husna Square, Hay Sharq, Qism Thani Asyut Asyut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University El Walideya El Bahareya, Qism Thani Asyut Asyut 2091110 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assiut Health Insurance Hospital El Hamra El Thania, El Fath, Asyut Asyut Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yassin Hassan yassinmesbah19@gmail.com +201111337373 Al-Azhar Street, Asmaa Allah Al-Husna Square, Hay Sharq, Qism Thani Asyut
City Postal code Country Position/Affiliation
Asyut Egypt Lecturer of Neurology Department Faculty of Medicine Al Azhar University Assiut
Role Name Email Phone Street address
Public Enquiries Yassin Hassan yassinmesbah19@gmail.com +201111337373 Al-Azhar Street, Asmaa Allah Al-Husna Square, Hay Sharq, Qism Thani Asyut
City Postal code Country Position/Affiliation
Asyut Egypt Lecturer of Neurology Department Faculty of Medicine Al Azhar University Assiut
Role Name Email Phone Street address
Scientific Enquiries Yassin Hassan yassinmesbah19@gmail.com +201111337373 Al-Azhar Street, Asmaa Allah Al-Husna Square, Hay Sharq, Qism Thani Asyut
City Postal code Country Position/Affiliation
Asyut Egypt Lecturer of Neurology Department Faculty of Medicine Al Azhar University Assiut
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized participant-level data will be made available upon reasonable request to the corresponding author, following the publication of the study results Informed Consent Form Data will be available starting 3 months after publication and ending 3 years after publication. Data requests will be reviewed by the principal investigator and the ethics committee of Al-Azhar University. Access will be granted to researchers who provide a methodologically sound proposal and have obtained necessary institutional ethical approval.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 10/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 30/07/2026 Updated to accurately reflect that the study was self-funded by the Principal Investigator, Dr. Yassin Hassan No fund, NA, NA, , Egypt, Other, NA Dr. Yassin Hassan, Al-Azhar Street, Asmaa Allah Al-Husna Square, Hay Sharq, Qism Thani Asyut, Asyut, , Egypt, Self Funded, NA
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 22/07/2026 No fund Self Funded, NA, NA, , Egypt, Self Funded, No fund, NA, NA, , Egypt, Other, NA