RightFit
RecruitingNot applicable

Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (4)

AZ

CA

FL

NY