Clinical trial NCT06763692: Low Intensity Focused Ultrasound for Parkinson's Disease
Official title: Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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

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 criteria: 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.
* 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.

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.
* 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.

Primary outcomes:
measure: Occurrence of Treatment Emergent Adverse Events
timeFrame: baseline and day 7, 30 and 90 after study procedure
Secondary outcomes:
measure: Effect of LIFU on visuospatial function,
timeFrame: baseline and day 7, 30 and 90 after study procedure
Other outcomes:
Locations:
Study officials:
References: