Non-invasive Transcranial Electrical Stimulation in MS

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04466228
Collaborator
(none)
60
1
3
23.5
2.6

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
  • Device: non-invasive transcranial electrical stimulation
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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis
Actual Study Start Date :
Oct 16, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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.

  2. 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

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04466228
Other Study ID Numbers:
  • FG-1908-34831
First Posted:
Jul 10, 2020
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021