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OpenTrials
Completed

NCT Number: NCT04466228

Non-invasive Transcranial Electrical Stimulation in MS

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Cognitive Impairment Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Sandler Neurosciences Center

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-invasive transcranial electrical stimulation

Device

Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2020
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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