Non-invasive Transcranial Electrical Stimulation in MS
Study Details
Study Description
Brief Summary
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Stim1 high dose This group will receive high dose non-invasive transcranial electrical stimulation |
Device: non-invasive transcranial electrical stimulation
Non-invasive transcranial electrical stimulation across the prefrontal cortex.
|
Experimental: Stim2 low dose This group will receive low dose non-invasive transcranial electrical stimulation |
Device: non-invasive transcranial electrical stimulation
Non-invasive transcranial electrical stimulation across the prefrontal cortex.
|
Sham Comparator: Sham control This group will receive sham control non-invasive transcranial electrical stimulation |
Device: non-invasive transcranial electrical stimulation
Non-invasive transcranial electrical stimulation across the prefrontal cortex.
|
Outcome Measures
Primary Outcome Measures
- Processing speed change from baseline assessment [Baseline and post-stimulation, up to 2 hours]
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.
- EVO performance change from baseline assessment [Baseline and post-stimulation, up to 2 hours]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 18-65,
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diagnosis of MS
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Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
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a minimum of 3 months since the last relapse
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Beck Depression Inventory<19
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normal hearing
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and no changes in MS or symptomatic medications in past 2 months
Exclusion Criteria:
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prior brain surgery
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clips in brain
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epilepsy or other neurological or non-affective psychiatric disorders
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pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UCSF Sandler Neurosciences Center | San Francisco | California | United States | 94158 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Riley Bove, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FG-1908-34831