Trial Outcomes & Findings for Non-invasive Transcranial Electrical Stimulation in MS (NCT NCT04466228)

Last Updated: 2023-12-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2023-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Transcranial Electrical Stimulation in MS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stim1 High Dose n=20 Participants 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.	Stim2 Low Dose n=20 Participants 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.	Sham Control n=20 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 7.6 • n=5 Participants	42.8 years STANDARD_DEVIATION 9.3 • n=7 Participants	47.4 years STANDARD_DEVIATION 8.0 • n=5 Participants	46.3 years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants	40 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Stim2 Low Dose n=20 Participants 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.	Stim1 High Dose n=20 Participants 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.	Sham Control n=20 Participants 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.
Processing Speed Change From Baseline Assessment pre-stim	41.65 score on a scale Standard Error 2.65	42.05 score on a scale Standard Error 2.68	44.4 score on a scale Standard Error 1.8
Processing Speed Change From Baseline Assessment post-stim	46.1 score on a scale Standard Error 2.81	44.8 score on a scale Standard Error 2.82	44.8 score on a scale Standard Error 1.4

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Stim1 High Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stim2 Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wan-Yu Hsu

University of California, San Francisco

Phone: +14153531140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place