Transcranial Focused Ultrasound Safety in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new wearable device called Attune ATTN201 that uses sound waves to stimulate specific parts of the brain. It focuses on people whose brain activity is being studied. The device aims to change brain activity by sending sound waves to precise areas without affecting other parts of the brain.
Will I have to stop taking my current medications?
The trial requires that you stop taking any psychotropic medications (drugs that affect your mood, thoughts, or behavior) at least 5 half-lives (the time it takes for the drug's active substance to reduce by half in your body) before the procedure. Additionally, you cannot be taking medications like stimulants, modafinil, thyroid medication, or steroids.
Is transcranial focused ultrasound generally safe for humans?
Research shows that transcranial focused ultrasound, including MR-guided focused ultrasound (MRgFUS), is generally safe for humans. Studies have demonstrated its safety in treating brain tumors, Parkinson's disease, essential tremor, and neuropathic pain, with low complication rates and no significant adverse effects when used correctly.12345
How is transcranial focused ultrasound treatment different from other treatments?
Transcranial focused ultrasound (tFUS) is unique because it is a non-invasive treatment that uses sound waves to target and treat specific areas in the brain without the need for surgery or anesthesia. It is guided by MRI, which allows for precise targeting and monitoring, and it does not involve ionizing radiation, reducing the risk of complications.23567
What data supports the effectiveness of the treatment Transcranial Focused Ultrasound?
Research shows that MR-guided focused ultrasound (MRgFUS), a type of transcranial focused ultrasound, is effective in treating conditions like Parkinson's disease, essential tremor, and neuropathic pain. It is a non-invasive method that can precisely target and treat areas in the brain, offering an alternative to traditional surgery with fewer complications.5891011
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 22-55 who speak English, can consent, and have no history of mental or physical illness. Women must not be pregnant and participants should not have metal implants. All must commit to the study schedule.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive focused ultrasound stimulation using the Attune ATTN201 device over the course of 1 month
Follow-up
Participants are monitored for safety and effectiveness after treatment, including EEG recordings and behavioral assessments
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Focused Ultrasound
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Attune Neurosciences
Collaborator
Attune Neurosciences Inc
Industry Sponsor