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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04586387

HM20018505

Details and patient eligibility

About

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/

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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