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NCT04586387 Clinical Trial

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

Healthy Clinical Trial

Official title:
The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04586387
Other study ID # HM20018505
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date July 8, 2022

Study information
Verified date May 2024
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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/

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date July 8, 2022
Est. primary completion date July 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• intermittent 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
• intermittent 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

Locations
Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)
Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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 approximately 7 days
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 approximately 7 days
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 approximately 7 days
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 approximately 7 days
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