HealthyNCT05792020
Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound
A study testing Focused Ultrasound Stimulation in people with Healthy, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Focused Ultrasound Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin A Caulfield contact
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Lisa M McTeague, PhD, (843) 792-8274, mcteague@musc.edu
Allison K Wilkerson, PhD, 843-792-4636, wilkersa@musc.edu
About this study
Official title: Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound (fUS) Over the Motor Cortex
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.
Read the 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
- Being tested
- Focused Ultrasound Stimulation
- Keywords
- Transcranial Focused Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Ultrasound StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Device: Focused Ultrasound Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Evoked Potential Amplitude
How has the focused ultrasound stimulation affected MEP amplitude
Measured: Immediate Post-Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study startJul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject, each participant will receive one excitatory course of stimulation and one inhibitory course of stimulation of the motor cortex.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- BRAINBox Solutions Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792020
- Sponsor's protocol ID
- Pro00124327
- Status last verified
- May 2026
- First submitted
- 17 Mar 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Parameterization, and Mechanism of Transcranial Focused Ultrasound (fUS) Over the Motor Cortex
- ClinicalTrials.gov ID
- NCT05792020
- Acronym / sponsor ID
- Pro00124327
- Conditions
- Healthy
- Keywords
- Transcranial Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- BRAINBox Solutions Inc
- Study start
- Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Within-subject, each participant will receive one excitatory course of stimulation and one inhibitory course of stimulation of the motor cortex.
| Arm | Type | Receives |
|---|---|---|
| Excitatory tFUS parameters effect on Motor Evoked Potentials | Experimental | Device: Focused Ultrasound StimulationAll participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 50% duty cycle. |
| Inhibitory tFUS parameters effect of Motor Evoked Potentials | Experimental | Device: Focused Ultrasound StimulationAll participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 5% duty cycle |
| Sham tFUS parameters effect of Motor Evoked Potentials | Sham comparator | Device: Focused Ultrasound StimulationAll 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Ultrasound StimulationThis 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. | Device | Excitatory tFUS parameters effect on Motor Evoked Potentials, Inhibitory tFUS parameters effect of Motor Evoked Potentials, Sham tFUS parameters effect of Motor Evoked Potentials |
Primary outcome
Motor Evoked Potential Amplitude
Time frame: Immediate Post-Stimulation
How has the focused ultrasound stimulation affected MEP amplitude
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin A Caulfield contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound Stimulation in people with Healthy, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M McTeague, Ph.D. (8437928274, mcteague@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Evoked Potential Amplitude (time frame: Immediate Post-Stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.