The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle
Study Overview
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/
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Brain stimulation over bicep muscle than finger (FDI) muscle.
Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.
Intervention: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle (Device)
Brain stimulation over bicep muscle than finger (FDI) muscle.
Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.
Intervention: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle (Device)
Brain stimulation over than finger (FDI) muscle than bicep muscle.
Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.
Intervention: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle (Device)
Brain stimulation over than finger (FDI) muscle than bicep muscle.
Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.
Intervention: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle (Device)
Outcomes
Primary Outcomes
Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle
Time Frame: 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
Time Frame: 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 Bicep Muscle
Time Frame: 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
Time Frame: approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Secondary Outcomes
No secondary outcomes reported