Multiple SclerosisNCT07160218
Effects of tDCS and Cognitive Rehabilitation on Cognition and Neural Plasticity in MS Patients
A study testing tDCS and Cognitive Rehabilitation in people with Multiple Sclerosis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this clinical trial is to evaluate whether transcranial direct current stimulation (tDCS) and cognitive rehabilitation can improve cognitive functions and neuronal plasticity in patients with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- tDCS and Cognitive Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- 2 Jan 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 50 years.
- Diagnosed with relapsing-remitting multiple sclerosis (RRMS).
- Mild disability, defined as EDSS < 5.
- Patients who attended the neurology clinic and are willing to participate.
Who cannot join
- Presence of psychiatric disorders requiring treatment with neuroleptics.
- History of seizures.
- Left-handed individuals.
- Recent MS relapse requiring steroid treatment.
- Pregnant women.
- History of brain surgery or presence of intracranial clips.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal Plasticity inPatients With Multiple Sclerosis: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether transcranial direct current stimulation (tDCS) and cognitive rehabilitation can improve cognitive functions and neuronal plasticity in patients with multiple sclerosis (MS). The participant population consists of MS patients (both sexes, adults), who commonly experience cognitive impairment in addition to physical and psychological symptoms.
The main questions it aims to answer are:
Does tDCS applied over the left dorsolateral prefrontal cortex improve cognitive abilities in MS patients?
Does the combination of tDCS and cognitive rehabilitation enhance neuroplasticity, as measured by DTI, BDNF levels, and acetylcholinesterase activity?
- Conditions
- Multiple Sclerosis
- Being tested
- tDCS, Cognitive Rehabilitation, Sham tDCS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC), delivered in 10 sessions over 2 weeks. This protocol targets cognitive improvement in MS patients
Cognitive RehabilitationDevice
computer-based cognitive rehabilitation exercises. Conducted in 10 sessions over 2 weeks to enhance attention, memory, and neuroplasticity in MS patients.
Sham tDCSDevice
Sham stimulation applied over the left DLPFC for 30 minutes, mimicking the sensation of tDCS without delivering active current, over 10 sessions, used as control to blind participants to the intervention
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC) Receives: Device: tDCS |
| tDCS+Cognitive training | Experimental | A 30-minute tDCS session with the cathode over the left DLPFC combined with computer-based cognitive rehabilitation training Receives: Device: tDCS; Device: Cognitive Rehabilitation |
| Sham tDCS | Sham comparator | Sham stimulation applied over the left DLPFC, mimicking the sensation of tDCS without delivering active current Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II)
The CVLT-II assesses verbal learning and memory through a word recall task. Scores include total recall, short-delay recall, and long-delay recall. Assessments will be conducted at baseline and after 4 weeks of intervention.
Measured: Baseline and immediately after 10 intervention sessions
Change in attention performance measured by Integrated Visual and Auditory Continuous Performance Test (IVA-2)
The IVA-2 evaluates visual and auditory attention and response control. Scores include full-scale attention quotient, visual attention, auditory attention, and response control. Assessments will be conducted at baseline and post-intervention to assess changes in attention performance
Measured: Baseline and immediately after 10 intervention sessions
Change in visuospatial memory performance measured by Rey-Osterrieth Complex Figure Test
The Rey-Osterrieth Complex Figure Test evaluates visuospatial constructional ability and memory. Participants copy a complex figure (copy trial) and then reproduce it from memory immediately and after a delay. Assessments will be conducted at baseline and after completion of the tDCS intervention to assess changes in visuospatial memory performance.
Measured: Baseline and immediately after 10 intervention sessions
Change in serum BDNF levels (ng/mL)
Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at baseline and after completion of the tDCS intervention. Changes in BDNF levels will be analyzed to assess neuroplasticity.
Measured: Baseline and immediately after 10 intervention sessions
Change in white matter integrity measured by Diffusion Tensor Imaging (DTI)
White matter integrity will be assessed using DTI MRI scans. Primary metrics include Fractional Anisotropy (FA) and Mean Diffusivity (MD) in predefined brain regions. Scans will be performed at baseline and after completion of the tDCS intervention to evaluate neuroplasticity-related changes
Measured: Baseline and immediately after 10 intervention sessions
Change in acetylcholinesterase (AChE) activity in blood (U/mL)
Acetylcholinesterase activity will be measured in blood samples using a spectrophotometric enzymatic assay. Samples will be collected at baseline and after completion of the tDCS intervention. Changes in AChE activity will be analyzed to assess cholinergic system function and neuroplasticity.
Measured: Baseline and immediately after 10 intervention sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Jan 2024
- Primary completion1 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehrdad Roozbeh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160218
- Sponsor's protocol ID
- IR.SBMU.PHNS.REC.1402.121
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available to qualified researchers. Data sharing will occur after the publication of the primary study results. Requests for data access will be considered on a case-by-case basis and can be initiated by contacting the corresponding author. Data will be shared under a data use agreement to ensure appropriate use and confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal Plasticity inPatients With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07160218
- Acronym / sponsor ID
- IR.SBMU.PHNS.REC.1402.121
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether transcranial direct current stimulation (tDCS) and cognitive rehabilitation can improve cognitive functions and neuronal plasticity in patients with multiple sclerosis (MS). The participant population consists of MS patients (both sexes, adults), who commonly experience cognitive impairment in addition to physical and psychological symptoms.
The main questions it aims to answer are:
Does tDCS applied over the left dorsolateral prefrontal cortex improve cognitive abilities in MS patients?
Does the combination of tDCS and cognitive rehabilitation enhance neuroplasticity, as measured by DTI, BDNF levels, and acetylcholinesterase activity?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCSA 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC) |
| tDCS+Cognitive training | Experimental | Device: tDCS, Device: Cognitive RehabilitationA 30-minute tDCS session with the cathode over the left DLPFC combined with computer-based cognitive rehabilitation training |
| Sham tDCS | Sham comparator | Device: Sham tDCSSham stimulation applied over the left DLPFC, mimicking the sensation of tDCS without delivering active current |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 and 50 years.
- Diagnosed with relapsing-remitting multiple sclerosis (RRMS).
- Mild disability, defined as EDSS < 5.
- Patients who attended the neurology clinic and are willing to participate.
Key exclusion criteria (6 listed)
- Presence of psychiatric disorders requiring treatment with neuroleptics.
- History of seizures.
- Left-handed individuals.
- Recent MS relapse requiring steroid treatment.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSA 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC), delivered in 10 sessions over 2 weeks. This protocol targets cognitive improvement in MS patients | Device | tDCS, tDCS+Cognitive training |
| Cognitive Rehabilitationcomputer-based cognitive rehabilitation exercises. Conducted in 10 sessions over 2 weeks to enhance attention, memory, and neuroplasticity in MS patients. | Device | tDCS+Cognitive training |
| Sham tDCSSham stimulation applied over the left DLPFC for 30 minutes, mimicking the sensation of tDCS without delivering active current, over 10 sessions, used as control to blind participants to the intervention | Device | Sham tDCS |
Primary outcome
Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II)
Time frame: Baseline and immediately after 10 intervention sessions
The CVLT-II assesses verbal learning and memory through a word recall task. Scores include total recall, short-delay recall, and long-delay recall. Assessments will be conducted at baseline and after 4 weeks of intervention.
Change in attention performance measured by Integrated Visual and Auditory Continuous Performance Test (IVA-2)
Time frame: Baseline and immediately after 10 intervention sessions
The IVA-2 evaluates visual and auditory attention and response control. Scores include full-scale attention quotient, visual attention, auditory attention, and response control. Assessments will be conducted at baseline and post-intervention to assess changes in attention performance
Change in visuospatial memory performance measured by Rey-Osterrieth Complex Figure Test
Time frame: Baseline and immediately after 10 intervention sessions
The Rey-Osterrieth Complex Figure Test evaluates visuospatial constructional ability and memory. Participants copy a complex figure (copy trial) and then reproduce it from memory immediately and after a delay. Assessments will be conducted at baseline and after completion of the tDCS intervention to assess changes in visuospatial memory performance.
Change in serum BDNF levels (ng/mL)
Time frame: Baseline and immediately after 10 intervention sessions
Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at baseline and after completion of the tDCS intervention. Changes in BDNF levels will be analyzed to assess neuroplasticity.
Change in white matter integrity measured by Diffusion Tensor Imaging (DTI)
Time frame: Baseline and immediately after 10 intervention sessions
White matter integrity will be assessed using DTI MRI scans. Primary metrics include Fractional Anisotropy (FA) and Mean Diffusivity (MD) in predefined brain regions. Scans will be performed at baseline and after completion of the tDCS intervention to evaluate neuroplasticity-related changes
Change in acetylcholinesterase (AChE) activity in blood (U/mL)
Time frame: Baseline and immediately after 10 intervention sessions
Acetylcholinesterase activity will be measured in blood samples using a spectrophotometric enzymatic assay. Samples will be collected at baseline and after completion of the tDCS intervention. Changes in AChE activity will be analyzed to assess cholinergic system function and neuroplasticity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided. Data will be made available to qualified researchers. Data sharing will occur after the publication of the primary study results. Requests for data access will be considered on a case-by-case basis and can be initiated by contacting the corresponding author. Data will be shared under a data use agreement to ensure appropriate use and confidentiality
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Cognitive Rehabilitation in people with Multiple Sclerosis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II) (time frame: Baseline and immediately after 10 intervention sessions). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.