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The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal plasticity in Patients with Multiple Sclerosis: A Randomized Controlled Trial

Protocol summary

Study aim
The aim is to evaluate the effect of transcranial direct current stimulation (tDCS) alone and combined with cognitive rehabilitation on attention, memory, and neuroplasticity markers including brain derived neurotrophic factor (BDNF) and diffusion tensor imaging (DTI) in multiple sclerosis patients.
Design
Interventional randomized controlled trial with block randomization, parallel design, double blind, sham controlled, phase not applicable, on 45 patients. Random sequence generated by statistical software and allocation concealment maintained using sealed opaque envelopes.
Settings and conduct
The study will be conducted at a multiple sclerosis center in tehran loghman hospital. After baseline assessment, patients will be randomly assigned to three groups. tDCS sessions will be delivered using preprogrammed devices. Patients, caregivers, and outcome assessors are blinded. Blood sampling for BDNF measurement and DTI imaging will be performed before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 50 years, diagnosis of relapsing remitting multiple sclerosis, EDSS less than five, presence of cognitive impairment based on neuropsychological tests, willingness and informed consent. Exclusion criteria: History of seizure, psychiatric disorder requiring antipsychotics, pregnancy, left handedness, recent relapse requiring steroids, history of brain surgery or intracranial metallic clip, unwillingness or inability to complete sessions.
Intervention groups
Group 1: Transcranial direct current stimulation (tDCS). Group 2: Transcranial direct current stimulation combined with cognitive rehabilitation. Group 3: Sham stimulation (inactive stimulation without effective current).
Main outcome variables
Improvement of attention; improvement of verbal and spatial memory; improvement of inhibitory control; change in BDNF level; change in DTI indices.

General information

Reason for update
Acronym
MS-NEURO
IRCT registration information
IRCT registration number: IRCT20220803055606N3
Registration date: 2025-09-20, 1404/06/29
Registration timing: prospective

Last update: 2025-09-20, 1404/06/29
Update count: 0
Registration date
2025-09-20, 1404/06/29
Registrant information
Name
alireza moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6522 4135
Email address
alirezamoradi_md@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-04-20, 1405/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal plasticity in Patients with Multiple Sclerosis: A Randomized Controlled Trial
Public title
Comparison of Transcranial Direct Current Stimulation (tDCS) Alone and Combined with Cognitive Rehabilitation on Improving Attention, Memory, and Inhibitory Control in Patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of relapsing remitting multiple sclerosis (RRMS) by a neurologist Age between 18 and 50 years Mild disability with EDSS less than 5 Presence of cognitive impairment based on neurocognitive tests (more than 2 SD below the mean in attention or inhibitory control) Willingness and informed consent to participate in the study
Exclusion criteria:
Presence of psychiatric disorder requiring antipsychotic treatment History of seizure or epilepsy Left handed individuals Recent MS relapse in the past month requiring steroid therapy Pregnancy History of brain surgery or intracranial metallic clip Unwillingness or inability to complete intervention sessions
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using permuted block randomization. The unit of randomization is individual. Block sizes will be randomly varied and patients will be allocated to three groups (tDCS, tDCS+Rehacom, Sham). The random sequence will be generated using statistical software. Allocation concealment will be ensured using opaque sealed envelopes that are opened only at the time of patient enrollment. The referring neurologist, the patient, and the cognitive assessor will all be blinded to the group assignments.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are blinded to their allocation to the active or sham stimulation groups (participant blinding). The clinicians and staff responsible for administering tDCS sessions are blinded by using preprogrammed devices with random codes that conceal whether the stimulation is active or sham (care provider blinding). The principal investigator remains unaware of patient allocation throughout the data collection process due to the use of coded randomization and sealed opaque envelopes (investigator blinding). Outcome assessors who conduct neurocognitive tests and questionnaires are blinded to patient group assignment (outcome assessor blinding). Data analysts receive coded datasets and perform statistical analyses without knowledge of group allocation (data analyst blinding). No independent Data Safety and Monitoring Committee (DSMC) has been established for this study.
Placebo
Used
Assignment
Parallel
Other design features
This study is a randomized, double-blind, parallel-group clinical trial. Patients with multiple sclerosis will be randomly assigned to three groups (transcranial direct current stimulation, transcranial direct current stimulation combined with cognitive rehabilitation, and sham). The unique feature of this trial is the simultaneous use of a non-pharmacological intervention (tDCS) combined with cognitive rehabilitation, along with the assessment of neuroplasticity biomarkers (BDNF and DTI).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1333635445
Approval date
2024-01-02, 1402/10/12
Ethics committee reference number
IR.SBMU.PHNS.REC.1402.121

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Change in attention score on the Integrated Visual and Auditory Continuous Performance Test in patients with multiple sclerosis
Timepoint
At baseline before starting the intervention; and immediately after completion of ten intervention sessions over two weeks
Method of measurement
Administration of the Integrated Visual and Auditory Continuous Performance Test using the standard computerized procedure, recording attention scores according to the official test manual

Secondary outcomes

1

Description
Change in serum level of brain derived neurotrophic factor in patients with multiple sclerosis
Timepoint
At baseline before starting the intervention; and immediately after completion of ten intervention sessions over two weeks
Method of measurement
Measurement of serum brain derived neurotrophic factor level using enzyme linked immunosorbent assay according to the manufacturer’s instructions

Intervention groups

1

Description
First intervention group: Patients will undergo ten sessions of transcranial direct current stimulation (tDCS). Each session lasts 30 minutes over two weeks (five sessions per week). The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3 according to the 10-20 system) and the cathodal electrode over the right shoulder. Stimulation intensity is 2 mA.
Category
Treatment - Devices

2

Description
Second intervention group: Intervention group 2: Patients will receive ten sessions of transcranial direct current stimulation (tDCS) as in group 1, combined with cognitive rehabilitation using Rehacom software. Training modules focus on attention, memory, and inhibitory control during the same two-week period.
Category
Treatment - Devices

3

Description
Control group: Control group: Patients will undergo ten sessions of sham transcranial direct current stimulation. Electrodes are placed in the same positions as in the intervention groups, but the current is delivered only for the initial 30 seconds and then switched off, producing no physiological effect.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Educational Hospital
Full name of responsible person
Kourosh Gharehgozlou
Street address
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Web page address
https://lhmc.sbmu.ac.ir/index.jsp?pageid=18901&p=1

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Roozbeh
Position
physician
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mehrdadroozbeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Roozbeh
Position
physician
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mehrdadroozbeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Roozbeh
Position
physician
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mehrdadroozbeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to ethical considerations, patient confidentiality, and restrictions related to privacy protection, individual participant data will not be shared. No further information is available.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The full study protocol, statistical analysis plan, informed consent form, and final clinical study report will be available.
When the data will become available and for how long
Access will start six months after publication of the main results and will remain available for at least five years.
To whom data/document is available
The documents will be available to academic researchers and recognized research institutions
Under which criteria data/document could be used
Use is permitted only for scientific and research purposes. Any commercial use or re-identification of patients is prohibited.
From where data/document is obtainable
Requests should be addressed to the principal investigator, Dr. Mehrdad Roozbeh, Shahid Beheshti University of Medical Sciences, Tehran. Email: mehrdadroozbeh@gmail.com
What processes are involved for a request to access data/document
Written requests will be reviewed, and upon approval by the research committee, the documents will be provided within two months.
Comments
No individual participant data will be shared.
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