Non-invasive Transcranial Electrical Stimulation in MS

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

Detailed Description
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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.

Official Title
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Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Cognitive Impairment

Intervention / Treatment
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* Device: non-invasive transcranial electrical stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stim1 high dose<br>This group will receive high dose non-invasive transcranial electrical stimulation | Device: non-invasive transcranial electrical stimulation<br>* Non-invasive transcranial electrical stimulation across the prefrontal cortex.<br>|
| Experimental: Stim2 low dose<br>This group will receive low dose non-invasive transcranial electrical stimulation | Device: non-invasive transcranial electrical stimulation<br>* Non-invasive transcranial electrical stimulation across the prefrontal cortex.<br>|
| Sham Comparator: Sham control<br>This group will receive sham control non-invasive transcranial electrical stimulation | Device: non-invasive transcranial electrical stimulation<br>* Non-invasive transcranial electrical stimulation across the prefrontal cortex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (pre-stim) and post-stimulation, up to 2 hours |