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

NCT04586387 | Completed Results FDA Device

• 1 other identifier: HM20018505
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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/

Conditions

Healthy

Keywords

transcranial magnetic stimulation; non-invasive brain stimulation; magnetic resonance imaging

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Brain stimulation over bicep muscle than finger (FDI) muscle.

EXPERIMENTAL

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; Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle

Brain stimulation over than finger (FDI) muscle than bicep muscle.

EXPERIMENTAL

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; Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle

Interventions

intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle DEVICE

repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head

Brain stimulation over bicep muscle than finger (FDI) muscle.; Brain stimulation over than finger (FDI) muscle than bicep muscle.

intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle DEVICE

repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head

Brain stimulation over bicep muscle than finger (FDI) muscle.; Brain stimulation over than finger (FDI) muscle than bicep muscle.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nonimpaired individuals
• free of contraindications for MRI and TMS

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Results Point of Contact

• Title: Carrie Peterson
• Organization: Virginia Commonwealth University

clpeterson@vcu.edu

804 827 5270

Study Officials

• Carrie Peterson, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will not be able to tell the difference if they are being given active vs sham stimulation but will receive both.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: November 9, 2020
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: May 3, 2024
• Results First Posted: December 18, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)