The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
May 1, 2024 updated by: Virginia Commonwealth University
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
|
|
Experimental: 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.
|
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
approximately 7 days
|
|
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
|
approximately 7 days
|
|
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
|
approximately 7 days
|
|
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
|
approximately 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carrie Peterson, PhD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2020
Primary Completion (Actual)
July 8, 2022
Study Completion (Actual)
July 8, 2022
Study Registration Dates
First Submitted
October 7, 2020
First Submitted That Met QC Criteria
October 7, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2024
Last Update Submitted That Met QC Criteria
May 1, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HM20018505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.