Trial Outcomes & Findings for The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy (NCT NCT04586387)

Results Overview

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

approximately 7 days

Results posted on

2024-05-03

Participant Flow

Total enrollment was 12 with all participants receiving both interventions

Participant milestones

Participant milestones
Measure	Brain Stimulation: Biceps Then FDI Brain stimulation	Brain Stimulation: FDI Then Biceps Brain stimulation
Overall Study STARTED	6	6
Overall Study Sham Stimulation	6	6
Overall Study Active Stimulation	6	6
Overall Study 3 Day Rest	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants This combines both groups.
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Sex: Female, Male Female	7 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants
Normalized corticomotor excitability	0.3891 Unitless (a normalized value) STANDARD_DEVIATION 0.314 • n=12 Participants

PRIMARY outcome

Timeframe: approximately 7 days

Population: nonimpaired

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Outcome measures

Outcome measures
Measure	All Study Participants n=12 Participants Both study groups
Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle	6.9 percentage of Mwave Standard Deviation 3.4

PRIMARY outcome

Timeframe: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Outcome measures

Outcome measures
Measure	All Study Participants n=12 Participants Both study groups
Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle	4.4 percentage of Mwave Standard Deviation 3.2

PRIMARY outcome

Timeframe: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Outcome measures

Outcome measures
Measure	All Study Participants n=12 Participants Both study groups
Change in Corticomotor Excitability With Active Stimulation on Finger Muscle	8.6 percentage of Mwave Standard Deviation 5.4

PRIMARY outcome

Timeframe: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Outcome measures

Outcome measures
Measure	All Study Participants n=12 Participants Both study groups
Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle	4.2 percentage of Mwave Standard Deviation 3.1

Adverse Events

Brain Stimulation

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

Carrie Peterson

Virginia Commonwealth University

Phone: 804 827 5270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place