Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound

NCT ID: NCT05792020

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Excitatory tFUS parameters effect on Motor Evoked Potentials

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

Group Type: EXPERIMENTAL

Focused Ultrasound Stimulation

Intervention Type: 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.

Inhibitory tFUS parameters effect of Motor Evoked Potentials

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

Group Type: EXPERIMENTAL

Focused Ultrasound Stimulation

Intervention Type: 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.

Sham tFUS parameters effect of Motor Evoked Potentials

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

Group Type: SHAM_COMPARATOR

Focused Ultrasound Stimulation

Intervention Type: 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.

Interventions

Focused Ultrasound Stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BRAINBox Solutions Inc

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Kevin Caulfield

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Central Contacts

Lisa M McTeague, Ph.D.

Role: CONTACT

mcteague@musc.edu

8437928274

Kevin A Caulfield

Role: CONTACT

caulfiel@musc.edu

Facility Contacts

Lisa M McTeague, PhD

Role: primary

mcteague@musc.edu

(843) 792-8274

Allison K Wilkerson, PhD

Role: backup

wilkersa@musc.edu

843-792-4636

Other Identifiers

Pro00124327

Identifier Type: -

Identifier Source: org_study_id