Recruiting · registry status

Following longer-term results of focused ultrasound treatment

Researchers collect safety and treatment outcomes after an ultrasound procedure targeting one side of the brain for advanced Parkinson’s movement complications.

Learning by observing or collecting information · Study reference: NCT05539196

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

Follow this study

Looking for volunteers

Start (reported actual date): 2023-01-23
Main measurements finished (planned): 2029-07-31
Study finished (planned): 2029-07-31

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 30 years to 99 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * Men and women, age 30 years and older. * Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care. * Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits. * Subject has signed and received a copy of the approved informed consent form. Exclusion Criteria: * Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

Full study name & original research details

Official study title

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

Original description

This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

Further description from the registry

This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro. The following assessments will be collected at Baseline, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years: Adverse Events (AEs) (does not apply to Baseline Visit) Medication usage MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire

Conditions reported: Movement Disorders; Neurology; Parkinsons Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT05539196 ↗ — RECRUITING; checked 2026-10-11

Study type: Observational
Interventions: Exablate Pallidotomy, Unilateral
Phases: Not reported
Sponsor: InSightec
Start date reported by registry: 2023-01-23 (actual)

Registry updated: 2026-03-20 · Status last verified by the registry submitter: 2026-03

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Kingsley Nwaogu · 2143048265 · clinicalresearchquestions@insightec.com

Julia Zhu · 2148462577 · clinicalresearchquestions@insightec.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Maryland, Baltimore

Baltimore, Maryland, United States

Recruiting

Kaitlyn Henry · 410-328-0939 · KHenry@som.umaryland.edu

Howard Eisenberg, MD

Weill Cornell Medicine

New York, New York, United States

Recruiting

Rachel Olovyannikov · (212) 746-7373 · rao4005@med.cornell.edu

Isabella Cipollone · (203) 917-9918 · isc4005@med.cornell.edu

Michael Kaplitt, MD PhD

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Recruiting

Giovanna Rocchio · 215-829-6720 · NPN@uphs.upenn.edu

Casey Halpern, MD

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Recruiting

Claire Starcke · 214-645-1568 · Charlton.Starcke@UTSouthwestern.edu

Bhavya Shah, MD

Ohnishi Neurological Center

Akashi, Hyōgo, Japan

Recruiting

Naotaka Satou · +81-78-938-1238 · info@onc.akashi.hyogo.jp

Yoshihiro Kuga, MD

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.