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The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stim1 high dose | Experimental | This group will receive high dose non-invasive transcranial electrical stimulation |
|
| Stim2 low dose | Experimental | This group will receive low dose non-invasive transcranial electrical stimulation |
|
| Sham control | Sham Comparator | This group will receive sham control non-invasive transcranial electrical stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive transcranial electrical stimulation | Device | Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riley Bove, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Sandler Neurosciences Center | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37925960 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stim1 High Dose | This group will receive high dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| FG001 | Stim2 Low Dose | This group will receive low dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| FG002 | Sham Control | This group will receive sham control non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stim1 High Dose | This group will receive high dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| BG001 | Stim2 Low Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The present report covers all collected data. In a formal data analysis, three participants were excluded from the analyses: 2 due to poor performance at baseline (lower than 2 standard deviation of all 60 participants); and 1 for not following instructions properly during post-stim assessment. | Posted | Mean | Standard Error | score on a scale | Baseline (pre-stim) and post-stimulation (up to 2 hours) |
|
At the end of the study session (10 minutes after the cessation of the stimulation).
At the end of the study (10 minutes after the cessation of the stimulation)., all participants were asked to complete a survey rating their perception of stimulation (headache, neck pain, scalp pain, tingling, itching, burning sensation, sleepiness, trouble concentrating, and acute mood change, phosphene) on a Likert scale from 0 (none) to 10 (not tolerable).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stim1 High Dose | This group will receive high dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wan-Yu Hsu | University of California, San Francisco | +14153531140 | wanyuhsu3@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 | Nov 28, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2022 | Sep 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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This group will receive low dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| BG002 | Sham Control | This group will receive sham control non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Stim1 High Dose | This group will receive high dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
| OG002 | Sham Control | This group will receive sham control non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. |
|
|
| Primary | 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. | EVO performance change from baseline assessment was not measured in the study. Therefore the analysis was not performed. | Posted | Baseline (pre-stim) and post-stimulation, up to 2 hours |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Stim2 Low Dose | This group will receive low dose non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Sham Control | This group will receive sham control non-invasive transcranial electrical stimulation non-invasive transcranial electrical stimulation: Non-invasive transcranial electrical stimulation across the prefrontal cortex. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |