Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outco… (NCT07207122) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
United States60 participantsStarted 2025-10-08
Plain-language summary
This is a pilot randomized, sham-controlled, double-blind, multi-center study evaluating the safety and preliminary effectiveness of the Gen0Bh Transcranial Focused Ultrasound System for the treatment of motor symptoms in individuals with idiopathic Parkinson's disease.
Who can participate
Age range
22 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 22 to 80 years.
* Diagnosis of idiopathic Parkinson's disease.
* MDS-UPDRS Part III score ≥25 in OFF-medication state at baseline.
* Stable dopaminergic therapy for at least 30 days prior to enrollment.
* English proficiency.
* Normal or corrective hearing and vision.
* Ability to provide informed consent (or availability of an LAR) and comply with protocol requirements.
Exclusion Criteria:
* Atypical or secondary Parkinsonism.
* Prior deep brain stimulation or intracranial surgery.
* MoCA score \<23.
* Severe psychiatric illness (e.g., psychosis, suicidality, untreated major depression).
* History of seizure or intracranial pathology.
* Significant neurologic disease (e.g. brain tumor, multiple sclerosis)
* Contraindication to MRI or ultrasound.
* Unstable systemic medical conditions.
* Active malignancy or history of cancer within the past 5 years.
* Pregnancy or breastfeeding.
* Participation in another interventional trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using transcranial focused ultrasound stimulation on the brain — since it's listed as Phase NA, what does that tell us about how much safety data already exists for this specific approach in Parkinson's patients, and how does that affect your opinion on whether it's appropriate for me to consider?
2The trial is measuring motor symptoms using the MDS-UPDRS Part III score while I'm off my Parkinson's medication — what does that mean in practice, and would I need to stop taking my medications before or during assessments, and how might that affect how I feel?
3One of the main things this study is tracking is serious adverse device events — given that this involves a device directing ultrasound energy at the brain, what kinds of side effects or risks should I be aware of and ask the research team about before considering participation?
4Since this trial is actively recruiting right now, how does it compare to my current treatment plan or any standard-of-care options we haven't tried yet — would it make more sense to pursue those first?
5How would participating in this trial affect my regular Parkinson's care, in terms of visit frequency, travel, or any changes to my existing medications or therapies?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in MDS-UPDRS Part III Total Score (OFF Medication State)
Timeframe: Baseline up to 6 weeks
2
Incidence of Serious Adverse Device Events (SADEs)