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

Intervention / Treatment

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

  • United States
    • 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.
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
Device: 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
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.
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
Device: 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

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

Virginia Commonwealth University

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.

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