Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound

NCT05792020 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Pro00124327
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Transcranial Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Motor Evoked Potential Amplitude

  How has the focused ultrasound stimulation affected MEP amplitude

  Immediate Post-Stimulation

Study Arms (3)

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.

Device: Focused Ultrasound Stimulation

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

Device: Focused Ultrasound Stimulation

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

Device: Focused Ultrasound Stimulation

Interventions

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.

Excitatory tFUS parameters effect on Motor Evoked Potentials; Inhibitory tFUS parameters effect of Motor Evoked Potentials; Sham tFUS parameters effect of Motor Evoked Potentials

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• BRAINBox Solutions Inc: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Central Study Contacts

Lisa M McTeague, Ph.D.

CONTACT

8437928274; mcteague@musc.edu

Kevin A Caulfield

CONTACT

caulfiel@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Device stimulation will be blinded by the outcomes assessor to maintain the blinding of the participants and care provider
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject, each participant will receive one excitatory course of stimulation and one inhibitory course of stimulation of the motor cortex.

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)