Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

NCT06401928 | Completed

• 1 other identifier: IPM-MAU
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Multiple Sclerosis Impact Scale (MSIS-29)

  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)

  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)

  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 Outcomes (2)

• psychomotor speed task

  up to 1 day after the intervention

• attention / vigilance task

  up to 1 day after the intervention

Study Arms (3)

active tDCS group

ACTIVE COMPARATOR

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

tDCS with cognitive rehabilitation group

EXPERIMENTAL

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

sham tDCS group

SHAM COMPARATOR

The patients in this group receive 10 daily sessions of 1.5-mA sham transcranial direct current stimulation (tDCS).

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation combined with cognitive training DEVICE

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.

tDCS with cognitive rehabilitation group

transcranial direct current stimulation DEVICE

Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days.

active tDCS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• being 25-55 years old
• providing written informed consent
• If female, a negative urine pregnancy test
• stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
• right handed

You may not qualify if:

• smoker
• pregnancy
• alcohol or substance dependence
• history of seizure
• history of other neurological disorders than MS
• history of head injury
• 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.

Sponsors & Collaborators

• The National Brain Mapping Laboratory (NBML): lead
• Mohaghegh Ardabili University: collaborator

Study Sites (1)

Multiple Sclerosis Association of Guilan

Rasht, Giulan, Iran

Location

Related Publications (1)

• Zakibakhsh N, Basharpoor S, Ghalyanchi Langroodi H, Narimani M, Nitsche MA, Salehinejad MA. Repeated prefrontal tDCS for improving mental health and cognitive deficits in multiple sclerosis: a randomized, double-blind, parallel-group study. J Transl Med. 2024 Sep 13;22(1):843. doi: 10.1186/s12967-024-05638-1.

  PMID: 39272101 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 7, 2024
• Study Start: February 28, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 31, 2024
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)