Recruiting · registry status

Following focused ultrasound treatment for Parkinson’s tremor

Researchers collect longer-term safety and effectiveness information after an ultrasound procedure for shaking not adequately controlled by medicine.

Learning by observing or collecting information · Study reference: NCT04991831

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 ↗

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Looking for volunteers

Start (reported actual date): 2022-04-28
Main measurements finished (planned): 2027-12
Study finished (planned): 2027-12

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: 1. Men and women, age 30 years and older 2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care. 3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits 4. 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 study.

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 Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

Original description

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Further description from the registry

This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD. The following assessments will be collected at Baseline,1, 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 * Clinical Rating Scale for Tremor (CRST) ON medication * Unified Parkinson's Disease Rating Scale Part III ON medication * EQ-5D-5L * WPAI-GH

Conditions reported: Tremor Associated With Tremor Dominant Parkinson's 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 · NCT04991831 ↗ — RECRUITING; checked 2026-10-11

Study type: Observational
Interventions: Unilateral thalamotomy
Phases: Not reported
Sponsor: InSightec
Start date reported by registry: 2022-04-28 (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.

Matt Hibert · 214-630-2000 · 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.

Miami Neuroscience Institute Baptist Health

Miami, Florida, United States

Recruiting

Justin Sporrer, MD · 786-596-2226 · JustinSp@baptisthealth.net

Josette Elysée · 786-596-1826 · JosetteE@BaptistHealth.net

Justin Sporrer, MD

Rush University

Chicago, Illinois, United States

Recruiting

Edgar Y Perez · 3129427391 · Edgar_Y_Perez@rush.edu

Neepa Patel, MD

Brigham and Women's Hospital

Boston, Massachusetts, United States

Recruiting

John Rolston, MD, PhD · jrolston@bwh.harvard.edu

Anna Ball · aball@bwh.harvard.edu

John Rolston, MD, PhD

Weill Cornell Medicine

New York, New York, United States

Recruiting

Michael Kaplitt, MD, PhD · mik2002@med.cornell.edu

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

Michael Kaplitt, MD, PhD

Novant Health Brain & Spine Surgery

Huntsville, North Carolina, United States

Recruiting

Charles Munyon, MD · cnmunyon@novanthealth.org

Darren Crawford · DarrenNCrawford@novanthealth.org

Charles Munyon, MD

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Recruiting

Courtney Cannon · 216-444-1057 · CANNONC2@ccf.org

Sean Nagel, MD

Miami Valley Hospital

Fairborn, Ohio, United States

Recruiting

Daniel Gaudin, MD · 419-481-6220 · dgaudin@premierhealth.com

Heather Bell · 937-208-6013 · hrbell@premierhealth.com

Daniel Gaudin, MD

University of Dundee

Dundee, Scotland, United Kingdom

Recruiting

Tom Gilbertson, PhD MBBS · t.gilbertson@dundee.ac.uk

Kayleigh Anderson · Kayleigh.anderson6@nhs.scot

Tom Gilbertson, PhD MBBS

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