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New treatment option for Parkinson Disease
Official title Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
ClinicalTrials.gov ID: NCT07207122
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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.
- 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 treatment trial.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.