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Clinical Trials/NCT05792020
NCT05792020Not yet recruitingNot Applicable

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

Medical University of South Carolina2 sites in 1 country25 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
25
Locations
2
Primary Endpoint
Motor Evoked Potential Amplitude

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Care Provider)

Masking Description

Device stimulation will be blinded by the outcomes assessor to maintain the blinding of the participants and care provider

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Excitatory tFUS parameters effect on Motor Evoked Potentials

Experimental

All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 50% duty cycle.

Intervention: Focused Ultrasound Stimulation (Device)

Inhibitory tFUS parameters effect of Motor Evoked Potentials

Experimental

All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 5% duty cycle

Intervention: Focused Ultrasound Stimulation (Device)

Sham tFUS parameters effect of Motor Evoked Potentials

Sham Comparator

All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will utilize an air-filled spacer to block stimulation from reaching the brain

Intervention: Focused Ultrasound Stimulation (Device)

Outcomes

Primary Outcomes

Motor Evoked Potential Amplitude

Time Frame: Immediate Post-Stimulation

How has the focused ultrasound stimulation affected MEP amplitude

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor
Principal Investigator

Kevin Caulfield

Principal Investigator

Medical University of South Carolina

Study Sites (2)

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