Non-invasive Transcranial Electrical Stimulation in MS

University of California San Francisco (UCSF)

Status: Completed

Conditions: Cognitive Impairment; Multiple Sclerosis

Treatments: Device: non-invasive transcranial electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04466228

FG-1908-34831

Details and patient eligibility

About

The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.

Full description

The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-65,
• diagnosis of MS
• Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
• a minimum of 3 months since the last relapse
• Beck Depression Inventory<19
• normal hearing
• and no changes in MS or symptomatic medications in past 2 months

Exclusion criteria

• prior brain surgery
• clips in brain
• epilepsy or other neurological or non-affective psychiatric disorders
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Stim1 high dose

Experimental group

Description:

This group will receive high dose non-invasive transcranial electrical stimulation

Treatment:

Device: non-invasive transcranial electrical stimulation

Stim2 low dose

Experimental group

Description:

This group will receive low dose non-invasive transcranial electrical stimulation

Treatment:

Device: non-invasive transcranial electrical stimulation

Sham control

Sham Comparator group

Description:

This group will receive sham control non-invasive transcranial electrical stimulation

Treatment:

Device: non-invasive transcranial electrical stimulation