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Completed

NCT Number: NCT06401928

Electrical Brain Stimulation for Treatment of Secondary Symptoms in 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Multiple Sclerosis Association of Guilan

Rasht, Giulan, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. psychomotor speed task

    Time frame: up to 1 day after the intervention

    Performance in the psychomotor speed task (Reaction Time task)

  2. attention / vigilance task

    Time frame: up to 1 day after the intervention

    Performance in the attention / vigilance task (Rapid Visual Information Processing task)

Sponsors and collaborators

Lead sponsor

The National Brain Mapping Laboratory (NBML)

Other

Collaborators

  • Mohaghegh Ardabili University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 7, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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