NCT04466228

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 4, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

July 6, 2020

Results QC Date

August 22, 2023

Last Update Submit

November 29, 2023

Conditions

Multiple SclerosisCognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline (pre-stim) and post-stimulation (up to 2 hours)

  • 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.

    Baseline (pre-stim) and post-stimulation, up to 2 hours

Study Arms (3)

Stim1 high dose

EXPERIMENTAL

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

Device: non-invasive transcranial electrical stimulation

Stim2 low dose

EXPERIMENTAL

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

Device: non-invasive transcranial electrical stimulation

Sham control

SHAM COMPARATOR

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

Device: non-invasive transcranial electrical stimulation

Interventions

non-invasive transcranial electrical stimulationDEVICE

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Sham controlStim1 high doseStim2 low dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Sandler Neurosciences Center

San Francisco, California, 94158, United States

Location

Related Publications (1)

  • Hsu WY, Zanto T, Park JE, Gazzaley A, Bove RM. Effects of transcranial alternating current stimulation on cognitive function in people with multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2023 Dec;80:105090. doi: 10.1016/j.msard.2023.105090. Epub 2023 Oct 19.

    PMID: 37925960DERIVED

MeSH Terms

Conditions

Multiple SclerosisCognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Wan-Yu Hsu
Organization
University of California, San Francisco
wanyuhsu3@gmail.com
+14153531140

Study Officials

  • Riley Bove, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 10, 2020

Study Start

October 16, 2020

Primary Completion

August 23, 2022

Study Completion

August 23, 2022

Last Updated

December 4, 2023

Results First Posted

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)