Cognitive Impairment, Multiple Sclerosis
Conditions
Brief summary
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.
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.
Interventions
DEVICEnon-invasive transcranial electrical stimulation
Non-invasive transcranial electrical stimulation across the prefrontal cortex.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Processing Speed Change From Baseline Assessment | 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. |
| EVO Performance Change From Baseline Assessment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Stim1 High Dose | Total | Sham Control | Stim2 Low Dose |
|---|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 7.6 | 46.3 years STANDARD_DEVIATION 8.5 | 47.4 years STANDARD_DEVIATION 8 | 42.8 years STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 11 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 14 Participants | 40 Participants | 15 Participants | 11 Participants |
| Region of Enrollment United States | 20 Participants | 60 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 17 Participants | 48 Participants | 17 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 12 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Baseline (pre-stim) and post-stimulation, up to 2 hours
Population: EVO performance change from baseline assessment was not measured in the study. Therefore the analysis was not performed.
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.
Time frame: Baseline (pre-stim) and post-stimulation (up to 2 hours)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stim2 Low Dose | Processing Speed Change From Baseline Assessment | pre-stim | 41.65 score on a scale | Standard Error 2.65 |
| Stim2 Low Dose | Processing Speed Change From Baseline Assessment | post-stim | 46.1 score on a scale | Standard Error 2.81 |
| Stim1 High Dose | Processing Speed Change From Baseline Assessment | post-stim | 44.8 score on a scale | Standard Error 2.82 |
| Stim1 High Dose | Processing Speed Change From Baseline Assessment | pre-stim | 42.05 score on a scale | Standard Error 2.68 |
| Sham Control | Processing Speed Change From Baseline Assessment | pre-stim | 44.4 score on a scale | Standard Error 1.8 |
| Sham Control | Processing Speed Change From Baseline Assessment | post-stim | 44.8 score on a scale | Standard Error 1.4 |