N/A
N=12
The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04586387 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle — 6.9 percentage of Mwave
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle (Device); intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle |
6.9 | — |
| PRIMARY Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle |
4.4 | — |
| PRIMARY Change in Corticomotor Excitability With Active Stimulation on Finger Muscle |
8.6 | — |
| PRIMARY Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle |
4.2 | — |
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/
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04586387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.