Low Intensity Focused Ultrasound for Parkinson's Disease

NCT06763692 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: RNI_NMD_PD
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment Emergent Adverse Events

  All adverse events that are related to LIFU will be assessed

  baseline and day 7, 30 and 90 after study procedure

Secondary Outcomes (1)

• Effect of LIFU on visuospatial function,

  baseline and day 7, 30 and 90 after study procedure

Study Arms (1)

LIFU Neuromodulation

EXPERIMENTAL

Device: LIFU Neuromodulation

Interventions

LIFU Neuromodulation DEVICE

Subjects will undergo a single LIFU of the target brain region

LIFU Neuromodulation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures.

Sponsors & Collaborators

• Ali Rezai: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director RNI

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 8, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02