Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401928
• Other study ID #: IPM-MAU
• Status: Completed
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2024
• Source: The National Brain Mapping Laboratory (NBML)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 31, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Multiple Sclerosis Association of Guilan	Rasht	Giulan

Sponsors (2)

Lead Sponsor	Collaborator
The National Brain Mapping Laboratory (NBML)	Mohaghegh Ardabili University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	psychomotor speed task	Performance in the psychomotor speed task (Reaction Time task)	up to 1 day after the intervention
Secondary	attention / vigilance task	Performance in the attention / vigilance task (Rapid Visual Information Processing task)	up to 1 day after the intervention