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Non-invasive Transcranial Electrical Stimulation in MS

Primary Purpose

Multiple Sclerosis, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-invasive transcranial electrical stimulation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Sandler Neurosciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Stim1 high dose

Stim2 low dose

Sham control

Arm Description

This group will receive high dose non-invasive transcranial electrical stimulation

This group will receive low dose non-invasive transcranial electrical stimulation

This group will receive sham control non-invasive transcranial electrical stimulation

Outcomes

Primary Outcome Measures

Processing speed change from baseline assessment
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
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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2020
Last Updated
December 1, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04466228
Brief Title
Non-invasive Transcranial Electrical Stimulation in MS
Official Title
Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stim1 high dose
Arm Type
Experimental
Arm Description
This group will receive high dose non-invasive transcranial electrical stimulation
Arm Title
Stim2 low dose
Arm Type
Experimental
Arm Description
This group will receive low dose non-invasive transcranial electrical stimulation
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
This group will receive sham control non-invasive transcranial electrical stimulation
Intervention Type
Device
Intervention Name(s)
non-invasive transcranial electrical stimulation
Intervention Description
Non-invasive transcranial electrical stimulation across the prefrontal cortex.
Primary Outcome Measure Information:
Title
Processing speed change from baseline assessment
Description
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.
Time Frame
Baseline and post-stimulation, up to 2 hours
Title
EVO performance change from baseline assessment
Description
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.
Time Frame
Baseline and post-stimulation, up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riley Bove, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Sandler Neurosciences Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-invasive Transcranial Electrical Stimulation in MS

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