Focused Ultrasound for Healthy Subjects

Overseen By Kevin A Caulfield

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Psychotropic medications

Disqualifiers: Neurological illness, Substance abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 sessions

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking any psychotropic medications (drugs that affect your mind, emotions, or behavior), you will need to stop taking them at least 5 half-lives (a period of time it takes for the drug's active substance to reduce by half in the body) before the procedure. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Focused Ultrasound Stimulation?

Research shows that focused ultrasound can modulate brain activity in animals without causing tissue damage, suggesting it could be a safe and precise way to influence brain function. This technology has potential for use in various neurological and psychiatric conditions, indicating its effectiveness in modulating brain activity. ^{1 2 3 4 5}

Is focused ultrasound generally safe for humans?

Focused ultrasound, including low intensity transcranial focused ultrasound (LIFU) and microfocused ultrasound with visualization (MFU-V), has been shown to be generally safe in humans. Studies report only mild and temporary side effects like neck pain, sleepiness, and redness, with no serious adverse effects when used correctly. Safety profiles are similar to other non-invasive brain stimulation techniques. ^{3 6 7 8 9}

How does focused ultrasound differ from other treatments for brain modulation?

Focused ultrasound is unique because it can non-invasively target deep brain structures with high precision, allowing for either stimulation or suppression of brain activity without causing tissue damage. This is different from other methods like transcranial magnetic stimulation, which cannot reach deep brain areas as effectively. ^{3 4 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy men and women aged 18-55 who speak English as their primary language. Participants must not be pregnant, have no history of mental or physical illness, no metal implants, and cannot have a personal or family history of seizures or epilepsy. They should not be on psychotropic medications recently nor have any substance abuse issues.

Inclusion Criteria

I am in good health with no history of serious illness or metal implants.

English as a primary language

Willingness to adhere to the tFUS and MRI study schedule

Exclusion Criteria

I or someone in my family has had a neurological illness or injury.

Hair in dreadlocks, braids, or weave

I have taken mental health medication within a certain time before the procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three sessions of Focused Ultrasound Stimulation to their motor hotspot with different parameters

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediate Post-Stimulation

Treatment Details

Interventions

• Focused Ultrasound Stimulation

Trial Overview The study is examining the safety and effects of Transcranial Focused Ultrasound (tFUS) on motor functions by measuring Motor Evoked Potentials (MEPs) and monitoring GABA and Glutamate concentrations in the brain among healthy individuals.

Participant Groups

Group I: Inhibitory tFUS parameters effect of Motor Evoked Potentials Experimental Treatment 1 Intervention

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 II: Excitatory tFUS parameters effect on Motor Evoked Potentials Experimental Treatment 1 Intervention

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 III: Sham tFUS parameters effect of Motor Evoked Potentials Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

BRAINBox Solutions Inc

Industry Sponsor

Trials

2

Recruited

2,000+

Findings from Research

Transcranial focused ultrasound (tFUS) can precisely target specific brain areas with low acoustic intensity, effectively modulating brain excitability and potentially promoting neural plasticity for neurorehabilitation.

The review highlights the excellent safety profile of tFUS, but emphasizes the need for new safety guidelines and recommendations for its use in healthy volunteers and clinical settings, based on a comprehensive analysis of acoustic parameters and their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review and Perspectives of Transcranial Focused Ultrasound Brain Stimulation. Lee, W., Weisholtz, DS., Strangman, GE., et al.[2023]

A study involving 120 participants evaluated the safety of low intensity transcranial focused ultrasound (LIFU) for neuromodulation, finding no serious adverse effects and only mild to moderate symptoms reported by 7 participants, which were generally transient.

The symptom profile from LIFU was similar to other non-invasive brain stimulation methods, suggesting that LIFU is a safe option for neuromodulation with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Legon, W., Adams, S., Bansal, P., et al.[2021]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

Pulsed focused ultrasound can effectively stimulate nerve structures and neurons, showing potential for various medical applications, including diagnosing neurological diseases and assessing skin and tissue sensitivity.

This technique may also aid in diagnosing hearing disorders and providing auditory information to individuals with specific types of hearing loss, highlighting its versatility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of focused ultrasound for stimulation of nerve structures. Gavrilov, LR.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A random phased-array for MR-guided transcranial ultrasound neuromodulation in non-human primates. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Application of focused ultrasound for research on pain. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Focused ultrasound modulates region-specific brain activity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Spatial Multitarget Ultrasound Neuromodulation System Using High-Powered 2-D Array Transducer. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review and Perspectives of Transcranial Focused Ultrasound Brain Stimulation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Early clinical experience using high intensity focused ultrasound for palliation of inoperable pancreatic cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Improved Target Specificity of Transcranial Focused Ultrasound Stimulation (TFUS) using Double-Crossed Ultrasound Transducers. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Use of focused ultrasound for stimulation of nerve structures. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Application of focused ultrasound for the stimulation of neural structures. [2022]