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Non-invasive Transcranial Electrical Stimulation in MS

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ClinicalTrials.gov Identifier: NCT04466228
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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
Multiple Sclerosis Cognitive Impairment Device: non-invasive transcranial electrical stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 16, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Processing speed change from baseline assessment [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466228


Contacts
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Contact: Wan-Yu Hsu, PhD (415) 353-1140 wan-yu.hsu@ucsf.edu

Locations
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United States, California
UCSF Sandler Neurosciences Center Recruiting
San Francisco, California, United States, 94158
Contact: Riley Bove, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Riley Bove, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04466228    
Other Study ID Numbers: FG-1908-34831
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases