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

NCT ID: NCT04586387

Last Updated: 2024-05-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2022-07-08

Brief Summary

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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/

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Participants will not be able to tell the difference if they are being given active vs sham stimulation but will receive both.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carrie Peterson, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HM20018505

Identifier Type: -

Identifier Source: org_study_id

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