Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: transcranial direct current stimulation; Device: transcranial direct current stimulation combined with cognitive training

• Registration Number: NCT06401928
• Lead Sponsor: The National Brain Mapping Laboratory (NBML)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tDCS group	transcranial direct current stimulation	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.
tDCS with cognitive rehabilitation group	transcranial direct current stimulation combined with cognitive training	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.
sham tDCS group	transcranial direct current stimulation	The patients in this group receive 10 daily sessions of 1.5-mA sham transcranial direct current stimulation (tDCS).

Primary Outcome Measures

Name	Time	Method
Mini sleep questionnaire (MSQ)	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.
Multiple Sclerosis Impact Scale (MSIS-29)	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.
and Depression Anxiety Stress Scale-21 (DASS-21)	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.

Secondary Outcome Measures

Name	Time	Method
psychomotor speed task	up to 1 day after the intervention	Performance in the psychomotor speed task (Reaction Time task)
attention / vigilance task	up to 1 day after the intervention	Performance in the attention / vigilance task (Rapid Visual Information Processing task)

Trial Locations

Locations (1)

Multiple Sclerosis Association of Guilan; 🇮🇷 Rasht, Giulan, Iran, Islamic Republic of