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NCT Number: NCT05792020

Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound

Through the BrainBox Initiative, investigators propose to study the effects of motor tFUS on Motor Evoked Potentials (MEPs) and GABA and Glutamate Concentrations in the Brain.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

tFUS is an emerging neuromodulatory tool that uses pulses of low-intensity acoustic waves to stimulate deep brain structures such as the thalamus. tFUS has recently been used to probe deep brain structures in unresponsive wakefulness, pain, anxiety, and other neuropsychiatric conditions. However, tFUS is restricted mainly by use in the MR scanner environment, thus limiting session numbers by scan cost and participant comfort. Furthermore, with few human studies to date, the parameter space and mechanisms of action warrant further elucidation. Using novel focused ultrasound methods, investigators can stimulate at a minimum penetration distance of 20mm, uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue. Specifically, investigators propose to study the effects of motor tFUS on motor-evoked potentials (MEPs) and GABA concentration. The proposed research is critical for understanding tFUS and advancing its therapeutic potential for future clinical trials.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female
  • Age 18-55
  • Endorse good health with no history of mental or physical illness or implanted metal
  • English as a primary language
  • Capacity to consent
  • Negative urine pregnancy test if a female of childbearing potential
  • Willingness to adhere to the tFUS and MRI study schedule

Exclusion criteria

  • Any psychotropic medication is taken within 5 half-lives of procedure time
  • Any head trauma resulting in loss of consciousness
  • Personal or family history of neurological illness or injury
  • Alcohol or substance abuse or dependence (other than tobacco) in the past week
  • Diagnosis or current treatment (pharmacological or otherwise) of any psychiatric condition
  • Pregnancy
  • Personal or family history of seizures or epilepsy
  • Claustrophobia or inability to stay still in the MR scanner environment
  • Any metal in the body
  • Other contraindications to electrical or electromagnetic stimulation
  • Hair in dreadlocks, braids, or weave
  • Diagnosis of COVID-19 in the past 14 days
  • Inability to adhere to the treatment schedule.

Treatment and study plan

Focused ultrasound stimulation

Device

This aim will test whether motor tFUS parameters thought to be excitatory (50% duty cycle) vs. inhibitory (5% duty cycle) elicit their predicted effects on MEPs before and after each of three stimulation blocks, using 50 MEPs at each time point.

Primary outcomes

  1. Motor Evoked Potential Amplitude

    Time frame: Immediate Post-Stimulation

    How has the focused ultrasound stimulation affected MEP amplitude

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin A Caulfield

CONTACT

[email protected]

Lisa M McTeague, Ph.D.

CONTACT

[email protected]

8437928274

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • BRAINBox Solutions Inc

Registry information

Official study title

Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound (fUS) Over the Motor Cortex

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2023
Registry last updated
May 22, 2026

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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