Tremor Associated With Tremor Dominant Parkinson's DiseaseNCT04991831
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
An observational study of Tremor Associated With Tremor Dominant Parkinson's Disease, run by InSightec at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 99 years
- Conditions the study is for
- Tremor Associated With Tremor Dominant Parkinson's Disease
- What is being tested?
- Unilateral thalamotomy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 28 Apr 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population enrolled in this registry will be comprised of male and female patients that plan to be treated for TDPD using the Exablate Neuro system.
Who may be able to join
- Men and women, age 30 years and older
- Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- Subject has signed and received a copy of the approved informed consent form
Who cannot join
- Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
John Rolston, MD, PhD, jrolston@bwh.harvard.edu
Anna Ball, aball@bwh.harvard.edu
- Recruiting
Rush University
Chicago, Illinois, 60612
Edgar Y Perez, 3129427391, Edgar_Y_Perez@rush.edu
Neepa Patel, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Courtney Cannon, 216-444-1057, CANNONC2@ccf.org
Sean Nagel, MD
- Recruiting
Miami Valley Hospital
Fairborn, Ohio, 45324
Daniel Gaudin, MD, 419-481-6220, dgaudin@premierhealth.com
Heather Bell, 937-208-6013, hrbell@premierhealth.com
- Recruiting
Novant Health Brain & Spine Surgery
Huntsville, North Carolina, 28708
Charles Munyon, MD, cnmunyon@novanthealth.org
Darren Crawford, DarrenNCrawford@novanthealth.org
- Recruiting
Miami Neuroscience Institute Baptist Health
Miami, Florida, 33176
Justin Sporrer, MD, 786-596-2226, JustinSp@baptisthealth.net
Josette Elysée, 786-596-1826, JosetteE@BaptistHealth.net
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Michael Kaplitt, MD, PhD, mik2002@med.cornell.edu
Isabella Cipollone, 203-917-9918, isc4005@med.cornell.edu
United Kingdom1 site, 1 recruiting
- Recruiting
University of Dundee
Dundee, Scotland, DD1 9SY
Tom Gilbertson, PhD MBBS, t.gilbertson@dundee.ac.uk
Kayleigh Anderson, Kayleigh.anderson6@nhs.scot
About this study
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.
Read the detailed description
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
- Being tested
- Unilateral thalamotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral thalamotomyDevice
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Unilateral thalamotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term adverse events.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.
Measured: Five years.
Secondary outcomes (1)
Tremor/motor intensity and impact on disability
Long term tremor motor scores and the impact of tremor on disability will be monitored using components of the Clinical Rating Scale for Tremor (CRST)
Measured: Five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start28 Apr 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tremor Associated With Tremor Dominant Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991831
- Sponsor's protocol ID
- PD012
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04991831
- Acronym / sponsor ID
- PD012
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease | – | Device: Unilateral thalamotomyThis is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol. |
Who may qualify
- Ages
- 30 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population enrolled in this registry will be comprised of male and female patients that plan to be treated for TDPD using the Exablate Neuro system.
Key inclusion criteria (4 listed)
- Men and women, age 30 years and older
- Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- Subject has signed and received a copy of the approved informed consent form
Key exclusion criteria (1 listed)
- Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral thalamotomyUnilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease. | Device | Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease |
Primary outcome
Long-term adverse events.
Time frame: Five years.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.
1 secondary outcome
Tremor/motor intensity and impact on disability
Time frame: Five years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tremor Associated With Tremor Dominant Parkinson's Disease, run by InSightec at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Hibert (214-630-2000, clinicalresearchquestions@insightec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term adverse events. (time frame: Five years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.