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Completed

NCT Number: NCT04586387

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

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/

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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