Non-invasive Transcranial Electrical Stimulation in MS

Not Applicable

Completed

• Conditions: Cognitive Impairment; Multiple Sclerosis
• Interventions: Device: non-invasive transcranial electrical stimulation

• Registration Number: NCT04466228
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-10
• Study Start: 2020-10-16
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Results First Submitted: 2023-08-22
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Results First Posted: 2023-12-04
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stim1 high dose	non-invasive transcranial electrical stimulation	This group will receive high dose non-invasive transcranial electrical stimulation
Stim2 low dose	non-invasive transcranial electrical stimulation	This group will receive low dose non-invasive transcranial electrical stimulation
Sham control	non-invasive transcranial electrical stimulation	This group will receive sham control non-invasive transcranial electrical stimulation

Primary Outcome Measures

Name	Time	Method
EVO Performance Change From Baseline Assessment	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	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.

Trial Locations

Locations (1)

UCSF Sandler Neurosciences Center; 🇺🇸 San Francisco, California, United States