Non-invasive Transcranial Electrical Stimulation in MS

University of California, San Francisco60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis Cognitive Impairment

Interventions

non-invasive transcranial electrical stimulationDEVICE

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

UCSF Sandler Neurosciences Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Processing Speed Change From Baseline Assessment

Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.

Time frame: Baseline (pre-stim) and post-stimulation (up to 2 hours)

EVO Performance Change From Baseline Assessment

EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.

Time frame: Baseline (pre-stim) and post-stimulation, up to 2 hours

Data from ClinicalTrials.gov

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