Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05792020
• Other study ID #: Pro00124327
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: Lisa M McTeague, Ph.D.
• Phone: 8437928274
• Email: mcteague[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	BRAINBox Solutions Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Evoked Potential Amplitude	How has the focused ultrasound stimulation affected MEP amplitude	Immediate Post-Stimulation