Healthy
Conditions
Keywords
transcranial magnetic stimulation, non-invasive brain stimulation, magnetic resonance imaging
Brief summary
The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/
Interventions
DEVICEintermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
DEVICEintermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Participants will not be able to tell the difference if they are being given active vs sham stimulation but will receive both.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* nonimpaired individuals * free of contraindications for MRI and TMS
Exclusion criteria
* musculoskeletal injury of the arm * neurologic deficit affecting motor or sensory function * concurrent severe medical illness * diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle | approximately 7 days | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability |
| Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle | approximately 7 days | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability |
| Change in Corticomotor Excitability With Active Stimulation on Finger Muscle | approximately 7 days | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability |
| Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle | approximately 7 days | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability |
Countries
United States
Participant flow
Pre-assignment details
Total enrollment was 12 with all participants receiving both interventions
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This combines both groups. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Normalized corticomotor excitability | 0.3891 Unitless (a normalized value) STANDARD_DEVIATION 0.314 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Time frame: approximately 7 days
Population: nonimpaired
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle | 6.9 percentage of Mwave | Standard Deviation 3.4 |
Primary
Change in Corticomotor Excitability With Active Stimulation on Finger Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Time frame: approximately 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Change in Corticomotor Excitability With Active Stimulation on Finger Muscle | 8.6 percentage of Mwave | Standard Deviation 5.4 |
Primary
Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Time frame: approximately 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle | 4.4 percentage of Mwave | Standard Deviation 3.2 |
Primary
Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Time frame: approximately 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle | 4.2 percentage of Mwave | Standard Deviation 3.1 |