Low Intensity Focused Ultrasound for Parkinson's Disease

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Parkinson's Disease

NCT06763692•Ali Rezai

Summary

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with parkinson's Disease

Detailed Description

The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for Parkinson's Disease

Eligibility

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and non-pregnant females aged 45 - 80 years at time of enrollment.
•Able and willing to give informed consent.
•Diagnosis of probable idiopathic Parkinson's disease by United Kingdom Parkinson's Disease
•Clinical diagnosis based on the Level II Movement Disorder Criteria and an FAQ less than or equal to 9.
•If on medication for the treatment of PD, or other medications for any other underlying medical conditions, must be on a stable dose for ≥4 weeks prior to Screening.
•Willing to not receive DBS or any other approved or experimental surgical or medical therapy for PD during the study period.
•Males and non-pregnant females aged 45 - 80 years at time of enrollment.
•Able and willing to give informed consent.
•Diagnosis of probable idiopathic Parkinson's disease by United Kingdom Parkinson's Disease
•Clinical diagnosis based on the Level II Movement Disorder Criteria and an FAQ less than or equal to 9.
+2 more criteria

Exclusion Criteria

•Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia).
•Active or chronic infection/inflammation
•Acute or chronic hemorrhages, specifically any lobar microbleeds with GRE and no siderosis or macro hemorrhages
•Tumor/space occupying lesion anywhere in the brain
•Participants who are unable or unwilling to lay flat and tolerate the required prolonged stationary position during treatment (approximately 2-3 hours).
•Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
•Participants with known unstable cardiac status or uncontrolled hypertension
•History of any clinically significant neurological disorder or procedure (e.g., brain surgery for Parkinson's disease, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
•Participant who has had deep brain stimulation or a prior stereotactic ablation of the basal ganglia, or thalamus.
•Currently participating in another clinical investigation with an active treatment arm or participated in any experimental therapy (drug or biologic or device) within 3 months prior to Screening.
+1 more criteria

Key Dates

Start Date

December 1, 2026

Primary Completion Date

March 30, 2027

Completion Date

March 30, 2028

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

LIFU Neuromodulation

DEVICE

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Low Intensity Focused Ultrasound for Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients