Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis

The National Brain Mapping Laboratory (NBML)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: transcranial direct current stimulation; Device: transcranial direct current stimulation combined with cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT06401928

IPM-MAU

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups

active tDCS group

Active Comparator group

Description:

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.

Treatment:

Device: transcranial direct current stimulation

Device: transcranial direct current stimulation

tDCS with cognitive rehabilitation group

Experimental group

Description:

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.

Treatment:

Device: transcranial direct current stimulation combined with cognitive training

sham tDCS group

Sham Comparator group

Description:

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

Treatment:

Device: transcranial direct current stimulation

Device: transcranial direct current stimulation