Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792020

Collaborator

BRAINBox Solutions Inc (Industry)

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Focused Ultrasound Stimulation	N/A

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, we can stimulate at a minimum penetration distance of 20mm, uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue. Specifically, we 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

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

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

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jun 15, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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	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.
Sham Comparator: 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	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Experimental: 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

Device: Focused Ultrasound Stimulation

Sham Comparator: 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

Device: Focused Ultrasound Stimulation

Outcome Measures

Primary Outcome Measures

Motor Evoked Potential Amplitude [Immediate Post-Stimulation]
How has the focused ultrasound stimulation affected MEP amplitude

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina
BRAINBox Solutions Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kevin Caulfield, Principal Investigator, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05792020

Other Study ID Numbers:

Pro00124327

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Kevin Caulfield, Principal Investigator, Medical University of South Carolina

Transcranial Focused Ultrasound

Study Results

No Results Posted as of Mar 30, 2023