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Completed

NCT Number: NCT07160218

Effects of tDCS and Cognitive Rehabilitation on Cognition and Neural Plasticity in MS Patients

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?

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Beheshti University of Medical Science

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

tDCS

Device

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 Rehabilitation

Device

computer-based cognitive rehabilitation exercises. Conducted in 10 sessions over 2 weeks to enhance attention, memory, and neuroplasticity in MS patients.

Sham tDCS

Device

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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