Parkinson DiseaseNCT03319485
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
A study testing ExAblate Pallidotomy in people with Parkinson Disease, run by InSightec at 20 sites in 8 countries.
Trial summary
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ExAblate Pallidotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 9 Feb 2018to 31 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age 30 years and older.
- Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months.
- Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
- MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
- Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
- Subject is able to communicate sensations during the ExAblate procedure.
- Subjects on stable antidepressant medications for at least 3 months
Who cannot join
- Hoehn and Yahr stage in the ON medication state of 3 or greater.
- Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
- Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
- Presence of significant cognitive impairment using MMSE ≤ 24.
- Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
Show all 22Show fewer
- Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
- Subjects with unstable cardiac status
- Severe hypertension (diastolic BP > 100 on medication).
- Current medical condition resulting in abnormal bleeding and/or coagulopathy.
- Receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
- Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter; a documented clinical coagulopathy; or INR coagulation studies exceeding the institution's laboratory standard
- Patient with kidney disease or on dialysis.
- Subjects with standard contraindications for MR imaging
- Significant claustrophobia that cannot be managed with mild medication.
- Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
- History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
- Subjects with a history of seizures within the past year.
- Subjects with brain tumors.
- Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
- Are participating or have participated in another clinical trial in the last 30 days.
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
United States11 sites
University of Maryland Medical System
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Palm Beach Neuroscience Institute/Sperling Medical Group
Boynton Beach, Florida, 33472
University of Virginia Health System
Charlottesville, Virginia, 22908
The Ohio State Wexner Medical Center
Columbus, Ohio, 43210
New York University Health Langone
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10065
Pennsylvania Hospital Department of Neurosurgery
Philadelphia, Pennsylvania, 19106
Mayo Clinic
Rochester, Minnesota, 55905
Swedish Medical Center
Seattle, Washington, 98122
Stanford University Medical Center
Stanford, California, 94305
Italy2 sites
Fondazione IRCCS Neurological Institute Carlo Besta
Milan, 20133
Azienda Ospedaliera Universitaria di Verona, Univerista di Verona
Verona, 37134
Spain2 sites
CINAC-Hospital HM Puerta del Sur
Móstoles, Madrid, 28938
Clinica Universidad De Navarra
Pamplona, Navarre, 31008
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Read the detailed description
The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- ExAblate Pallidotomy, Sham ExAblate Pallidotomy
- Keywords
- ExAblate, MRgFUS, Pallidotomy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate PallidotomyDevice
Also called MRgFUS, Pallidotomy
ExAblate Pallidotomy for Parkinson's Disease
Sham ExAblate PallidotomyDevice
ExAblate MRgFUS Sham Procedure
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Pallidotomy | Experimental | ExAblate treatment for Advanced Idiopathic Parkinson's Disease Receives: Device: ExAblate Pallidotomy |
| Sham ExAblate Pallidotomy | Sham comparator | Sham (fake) treatment Receives: Device: Sham ExAblate Pallidotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Analysis
Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
Measured: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment
Secondary outcomes (1)
Severity of Device and Procedure related complications
To evaluate of the incidence and severity of device- and procedure-related
Measured: At the time of ExAblate Pallidotomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start9 Feb 2018
- Primary completion25 Jul 2024
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319485
- Sponsor's protocol ID
- PD006
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2017
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Krishna V, Fishman PS, Eisenberg HM, Kaplitt M, Baltuch G, Chang JW, Chang WC, Martinez Fernandez R, Del Alamo M, Halpern CH, Ghanouni P, Eleopra R, Cosgrove R, Guridi J, Gwinn R, Khemani P, Lozano AM, McDannold N, Fasano A, Constantinescu M, Schlesinger I, Dalvi A, Elias WJ. Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson's Disease. N Engl J Med. 2023 Feb 23;388(8):683-693. doi: 10.1056/NEJMoa2202721.
PubMed 36812432
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 Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System
- ClinicalTrials.gov ID
- NCT03319485
- Acronym / sponsor ID
- PD006
- Conditions
- Parkinson Disease
- Keywords
- ExAblate, MRgFUS, Pallidotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Oct 2017 (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.
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Detailed description
The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ExAblate Pallidotomy | Experimental | Device: ExAblate PallidotomyExAblate treatment for Advanced Idiopathic Parkinson's Disease |
| Sham ExAblate Pallidotomy | Sham comparator | Device: Sham ExAblate PallidotomySham (fake) treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women, age 30 years and older.
- Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months.
- Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
- MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
Key exclusion criteria (22 listed)
- Hoehn and Yahr stage in the ON medication state of 3 or greater.
- Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
- Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
- Presence of significant cognitive impairment using MMSE ≤ 24.
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 |
|---|---|---|
| ExAblate PallidotomyAlso: MRgFUS, PallidotomyExAblate Pallidotomy for Parkinson's Disease | Device | ExAblate Pallidotomy |
| Sham ExAblate PallidotomyExAblate MRgFUS Sham Procedure | Device | Sham ExAblate Pallidotomy |
Primary outcome
Responder Analysis
Time frame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment
Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
1 secondary outcome
Severity of Device and Procedure related complications
Time frame: At the time of ExAblate Pallidotomy procedure
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.
- Derived from this study: PubMed 36812432Krishna V, Fishman PS, Eisenberg HM, Kaplitt M, Baltuch G, Chang JW, Chang WC, Martinez Fernandez R, Del Alamo M, Halpern CH, Ghanouni P, Eleopra R, Cosgrove R, Guridi J, Gwinn R, Khemani P, Lozano AM, McDannold N, Fasano A, Constantinescu M, Schlesinger I, Dalvi A, Elias WJ. Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson's Disease. N Engl J Med. 2023 Feb 23;388(8):683-693. doi: 10.1056/NEJMoa2202721.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate Pallidotomy in people with Parkinson Disease, run by InSightec at 20 sites in 8 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 8 inclusion and 22 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: under way, not looking for participants, 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 20 sites in United States, Italy, Spain, Canada, Israel and 3 more countries. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Analysis (time frame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319485, which also lists 1 linked publication.
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.