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

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04586387
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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/

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: intermittent theta burst stimulation (iTBS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
• Actual Study Start Date: Nov 9, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active brain stimulation	Device: intermittent theta burst stimulation (iTBS); repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
Sham Comparator: Inactive brain stimulation inactive TMS	Device: intermittent theta burst stimulation (iTBS); repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head

Outcome Measures

Primary Outcome Measures

1. Change in corticomotor excitability [approximately 7 days]

   The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: Carrie Peterson, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT04586387
• Other Study ID Numbers: HM20018505
• First Posted: Oct 14, 2020
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Virginia Commonwealth University: transcranial magnetic stimulation; non-invasive brain stimulation; magnetic resonance imaging

Study Results

No Results Posted as of Dec 17, 2021