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

NCT ID: NCT07160218

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2025-08-15

Brief Summary

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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?

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS

A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC)

Group Type EXPERIMENTAL

tDCS

Intervention Type 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

tDCS+Cognitive training

A 30-minute tDCS session with the cathode over the left DLPFC combined with computer-based cognitive rehabilitation training

Group Type EXPERIMENTAL

tDCS

Intervention Type 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

Intervention Type DEVICE

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

Sham tDCS

Sham stimulation applied over the left DLPFC, mimicking the sensation of tDCS without delivering active current

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type 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

Interventions

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tDCS

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

Intervention Type DEVICE

Cognitive Rehabilitation

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

Intervention Type DEVICE

Sham tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mehrdad Roozbeh

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shahid Beheshti University of Medical Science

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.SBMU.PHNS.REC.1402.121

Identifier Type: -

Identifier Source: org_study_id

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