Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

August 4, 2026 updated by: Mohammad Ali Salehinejad, PhD, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The National Brain Mapping Laboratory (NBML)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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