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Non-invasive Transcranial Electrical Stimulation in MS

NCT ID: NCT04466228

Last Updated: 2023-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2022-08-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Sclerosis Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Stim1 high dose

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

Group Type EXPERIMENTAL

non-invasive transcranial electrical stimulation

Intervention Type DEVICE

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Stim2 low dose

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

Group Type EXPERIMENTAL

non-invasive transcranial electrical stimulation

Intervention Type DEVICE

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Sham control

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

Group Type SHAM_COMPARATOR

non-invasive transcranial electrical stimulation

Intervention Type DEVICE

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Interventions

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non-invasive transcranial electrical stimulation

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Riley Bove, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Sandler Neurosciences Center

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37925960 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FG-1908-34831

Identifier Type: -

Identifier Source: org_study_id