Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

NCT ID: NCT06401928

Last Updated: 2024-05-08

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2024-01-31

Brief Summary

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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.

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 Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

transcranial direct current stimulation combined with cognitive training

Intervention Type 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.

sham tDCS group

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

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

transcranial direct current stimulation

Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohaghegh Ardabili University

UNKNOWN

Sponsor Role collaborator

The National Brain Mapping Laboratory (NBML)

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ali Salehinejad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Multiple Sclerosis Association of Guilan

Rasht, Giulan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 39272101 (View on PubMed)

Other Identifiers

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IPM-MAU

Identifier Type: -

Identifier Source: org_study_id

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