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Clinical Trials/NCT04466228
NCT04466228
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country60 target enrollmentOctober 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of California, San Francisco
Enrollment
60
Locations
1
Primary Endpoint
EVO Performance Change From Baseline Assessment
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2020
End Date
August 23, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

EVO Performance Change From Baseline Assessment

Time Frame: Baseline (pre-stim) 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.

Processing Speed Change From Baseline Assessment

Time Frame: Baseline (pre-stim) 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.

Study Sites (1)

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