The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: 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

• Registration Number: NCT04586387
• Lead Sponsor: Virginia Commonwealth University

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/

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Study Start: 2020-11-09
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-08
• Results First Submitted: 2023-09-06
• Results First Submitted QC: 2023-11-28
• Results First Posted: 2023-12-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brain stimulation over than finger (FDI) muscle than bicep muscle.	intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger 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.
Brain stimulation over bicep muscle than finger (FDI) muscle.	intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger 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.
Brain stimulation over than finger (FDI) muscle than bicep muscle.	intermittent theta burst stimulation (iTBS) with sham and then active stimulation over 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.
Brain stimulation over bicep muscle than finger (FDI) muscle.	intermittent theta burst stimulation (iTBS) with sham and then active stimulation over 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.

Primary Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States