Non-invasive Transcranial Electrical Stimulation in MS

November 29, 2023 updated by: University of California, San Francisco

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Sandler Neurosciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Riley Bove, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2020

Primary Completion (Actual)

August 23, 2022

Study Completion (Actual)

August 23, 2022

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-1908-34831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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