Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

March 15, 2026 updated by: Mohammad Ali Salehinejad, The National Brain Mapping Laboratory (NBML)

Electrical Brain Stimulation for Improving Mental Health and Cognitive Functioning in Patients With Multiple Sclerosis

Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunction. As a result, the disease burden is high, and treatment options are limited. In this randomized, double-blind study, the investigators planned to use repeated electrical stimulation and assess mental health-related variables (e.g., quality of life, sleep, psychological distress) and cognitive dysfunction in patients with MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
    • Giulan
      • Rasht, Giulan, Iran
        • Multiple Sclerosis Association of Guilan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. diagnosis of MS according to the diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria (Polman et al., 2011), certified by a professional neurologist
  2. being 25-55 years old
  3. providing written informed consent
  4. If female, a negative urine pregnancy test
  5. stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
  6. right handed

Exclusion Criteria:

  1. smoker
  2. pregnancy
  3. alcohol or substance dependence
  4. history of seizure
  5. history of other neurological disorders than MS
  6. history of head injury
  7. presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active tDCS group
The patients in this group receive 10 daily sessions of 1.5-mA transcranial direct current stimulation (tDCS) targeting the left lateral prefrontal cortex and right orbitofrontal cortex with anodal and cathodal stimulation respectively.
Device: transcranial direct current stimulation
Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days.
Device: transcranial direct current stimulation
Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days.
Experimental: tDCS with cognitive rehabilitation group
The patients in this group receive 10 daily sessions of 1.5-mA transcranial direct current stimulation (tDCS) followed by a 30-minute cognitive training intervention.
Device: transcranial direct current stimulation combined with cognitive training
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on 10 consecutive days. Each session is followed by 30 minutes cognitive training in which patients conduct several computerized cognitive tests.
Sham Comparator: sham tDCS group
The patients in this group receive 10 daily sessions of 1.5-mA sham transcranial direct current stimulation (tDCS).
Device: transcranial direct current stimulation
Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days.
Device: transcranial direct current stimulation
Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: up to 1 day after the intervention
The MSIS-29 is a questionnaire that comprises of 29 questions. The initial 20 questions are related to the physical impact, whereas the last 9 questions focus on the psychological impact. Each question is rated on a scale of 1 to 5, where 1 indicates "not at all" and 5 indicates "extremely". There are five response options available for the respondents to choose from.
up to 1 day after the intervention
and Depression Anxiety Stress Scale-21 (DASS-21)
Time Frame: up to 1 day after the intervention
The DASS-21 is a tool used to assess the severity of symptoms related to depression, anxiety, and stress in individuals who have not been diagnosed before. The assessment has three scales, and responses to each are measured on a four-point Likert scale, ranging from 0 to 3.
up to 1 day after the intervention
Mini sleep questionnaire (MSQ)
Time Frame: up to 1 day after the intervention
The Mini Sleep Questionnaire (MSQ) is used to screen for sleep disturbances in clinical populations. It consists of 10 items, each scored on a seven-point Likert scale ranging from "never" to "always". The questionnaire measures insomnia and oversleeping, with a high score indicating excessive sleepiness and a low score indicating insomnia.
up to 1 day after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychomotor speed task
Time Frame: up to 1 day after the intervention
Performance in the psychomotor speed task (Reaction Time task)
up to 1 day after the intervention
attention / vigilance task
Time Frame: up to 1 day after the intervention
Performance in the attention / vigilance task (Rapid Visual Information Processing task)
up to 1 day after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The National Brain Mapping Laboratory (NBML)

Collaborators

Mohaghegh Ardabili University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM-MAU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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