Recruiting

Exablate 4000

Sponsor:

InSightec

Code:

NCT04991831

Conditions

Tremor Associated With Tremor Dominant Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Unilateral thalamotomy

Study Details

Brief summary:

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.

Conditions

Tremor Associated With Tremor Dominant Parkinson's Disease

Study ID

NCT04991831

Start date

Apr 28, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease

This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.

Interventions

Unilateral thalamotomy

Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.

Primary outcome measure

  • Long-term adverse events. [ Time Frame: Five years. ]

Central Contacts and Locations

Central contacts

Matt Hibert

214-630-2000clinicalresearchquestions@insightec.com

Locations

Miami Neuroscience Institute Baptist Health

Recruiting

Miami, Florida, United States, 33176

Contacts

Justin Sporrer, MD

786-596-2226JustinSp@baptisthealth.net

Josette Elysée

786-596-1826JosetteE@BaptistHealth.net

Principal Investigator:

Justin Sporrer, MD

Rush University

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Edgar Y Perez

3129427391Edgar_Y_Perez@rush.edu

Principal Investigator:

Neepa Patel, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

John Rolston, MD, PhD

jrolston@bwh.harvard.edu

Anna Ball

aball@bwh.harvard.edu

Principal Investigator:

John Rolston, MD, PhD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Michael Kaplitt, MD, PhD

mik2002@med.cornell.edu

Isabella Cipollone

203-917-9918isc4005@med.cornell.edu

Principal Investigator:

Michael Kaplitt, MD, PhD

Novant Health Brain & Spine Surgery

Recruiting

Huntsville, North Carolina, United States, 28708

Contacts

Charles Munyon, MD

cnmunyon@novanthealth.org

Darren Crawford

DarrenNCrawford@novanthealth.org

Principal Investigator:

Charles Munyon, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Courtney Cannon

216-444-1057CANNONC2@ccf.org

Principal Investigator:

Sean Nagel, MD

Miami Valley Hospital

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Daniel Gaudin, MD

419-481-6220dgaudin@premierhealth.com

Heather Bell

937-208-6013hrbell@premierhealth.com

Principal Investigator:

Daniel Gaudin, MD

More Information

Sponsor

InSightec

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InSightec on 2026-03-20.