Parkinson DiseaseNCT04728295
Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
A study testing Exablate 4000 in people with Parkinson Disease, run by InSightec at 9 sites in 3 countries.
Trial summary
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD). 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 4000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 14 May 2021to 1 Dec 2028
- 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, desiring bilateral treatment option with second side staged at 6 months.
- Subject is able and willing to give informed consent and able to attend all study visits
- Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Motor complications of PD on optimum medical treatment
- Subject is on a stable dose of all PD medications for 30 days prior to screening visit
- Subject is able to communicate sensations during the Exablate procedure.
Who cannot join
- Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subject with significant cognitive impairment as determined by the neuropsychologist.
- Subject has 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.
- Subject with unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation
- Women of childbearing potential who are pregnant or lactating
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
Show all 29Show fewer
- Subject with unstable cardiac status or severe hypertension including:
- Documented myocardial infarction within six months of enrollment
- Unstable angina on medication
- Unstable or worsening congestive heart failure
- Left ventricular ejection fraction below the lower limit of normal
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Diastolic BP > 100 on medication
- Subject with history of abnormal bleeding, hemorrhage, or coagulopathy including:
- Subject 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.
- History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months
- Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
- Subject is 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.
- Subject with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis.
- Subjects with a history of seizures within the past year.
- Subject with an intracranial brain tumor
- Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, liver failure, blood dyscrasias, etc.
- Any illness that in the investigator's opinion preclude participation in this study.
- Subject with standard contraindications for MR imaging such as implanted metallic devices
- Subject who had prior deep brain stimulation of the basal ganglia or thalamus.
- Subjects who are unable to tolerate the required prolonged stationary supine position during treatment.
- Subject who is participating in another clinical investigation with an active treatment arm in the last 30 days.
- Subject who is unable to communicate with the investigator and staff.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States6 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Rush University Medical Center
Chicago, Illinois, 60612
Delray Medical Center
Delray Beach, Florida, 33484
New York University Langone
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10065
Stanford
Palo Alto, California, 94304
Spain2 sites
Neurology, Hospital Universitario HM Puerta del Sur (HM CINAC)
Madrid
Clínica Universidad de Navarra
Pamplona
About this study
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).
Read the detailed description
This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 10 sites.
Subjects will undergo an Exablate index procedure targeting the PTT and will be seen at 1-week,1-, 3-, and 6- months post treatment. At the 6-month visit, subjects will be evaluated for an Exablate procedure on the other side.
- Conditions
- Parkinson Disease
- Being tested
- Exablate 4000
- Keywords
- Exablate, MRgFUS, Pallidothalamic Tract
- 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 4000Device
Also called MRgFUS
Exablate Pallidothalamic Tractotomy
| Study group | Role | What they receive |
|---|---|---|
| Exablate Pallidothalamic Tractotomy | Experimental | Exablate treatment for Advanced Idiopathic Parkinson's Disease Receives: Device: Exablate 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication
OFF-medication, Upper + Lower Extremity motor score from the MDS-UPDRS Part III comparing Month 3 post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.
Measured: Up to Month 3 post Bilateral Treatment
Secondary outcomes (1)
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part II
MDS-UPDRS Part II - Activities of Daily living comparing all Bilateral scheduled visits to Baseline. Lower score on the scale means a better outcome.
Measured: Up to Month 12 post Bilateral Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start14 May 2021
- Primary completion28 Mar 2024
- Study completion1 Dec 2028 (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
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a bilateral study. Subjects will be treated on one side of the brain and will be allowed to receive treatment on the other side if eligible.
- Masking
- None (open label)
- 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
- NCT04728295
- Sponsor's protocol ID
- PD014
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Dalvi A, Eisenberg HM, Wu P, Zucker L, Chang WC, Sarva H, Fishman PS, Buch VP, Matarazzo M, Del Alamo M, Rodriguez-Oroz MC, Gonzalez-Quarante LH, Sani S, Ghanouni P, Patel N, Pourfar M, Mogilner A, Obeso JA, Kaplitt MG. Safety and efficacy of staged, bilateral magnetic resonance-guided focused ultrasound pallidothalamic tractotomy for motor complications of Parkinson's disease: a prospective, multicentre, single-arm trial. Lancet Neurol. 2026 Jul;25(7):654-663. doi: 10.1016/S1474-4422(26)00142-0.
PubMed 42309086
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT04728295
- Acronym / sponsor ID
- PD014
- Conditions
- Parkinson Disease
- Keywords
- Exablate, MRgFUS, Pallidothalamic Tract
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 Jan 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.
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).
Detailed description
This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 10 sites.
Subjects will undergo an Exablate index procedure targeting the PTT and will be seen at 1-week,1-, 3-, and 6- months post treatment. At the 6-month visit, subjects will be evaluated for an Exablate procedure on the other side.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a bilateral study. Subjects will be treated on one side of the brain and will be allowed to receive treatment on the other side if eligible.
| Arm | Type | Receives |
|---|---|---|
| Exablate Pallidothalamic Tractotomy | Experimental | Device: Exablate 4000Exablate treatment for Advanced Idiopathic Parkinson's Disease |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, age 30 years and older, desiring bilateral treatment option with second side staged at 6 months.
- Subject is able and willing to give informed consent and able to attend all study visits
- Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Motor complications of PD on optimum medical treatment
- Subject is on a stable dose of all PD medications for 30 days prior to screening visit
Key exclusion criteria (29 listed)
- Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subject with significant cognitive impairment as determined by the neuropsychologist.
- Subject has 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.
- Subject with unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation
- Women of childbearing potential who are pregnant or lactating
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 4000Also: MRgFUSExablate Pallidothalamic Tractotomy | Device | Exablate Pallidothalamic Tractotomy |
Primary outcome
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication
Time frame: Up to Month 3 post Bilateral Treatment
OFF-medication, Upper + Lower Extremity motor score from the MDS-UPDRS Part III comparing Month 3 post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.
1 secondary outcome
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part II
Time frame: Up to Month 12 post Bilateral Treatment
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 17 Feb 2025.
- Derived from this study: PubMed 42309086Dalvi A, Eisenberg HM, Wu P, Zucker L, Chang WC, Sarva H, Fishman PS, Buch VP, Matarazzo M, Del Alamo M, Rodriguez-Oroz MC, Gonzalez-Quarante LH, Sani S, Ghanouni P, Patel N, Pourfar M, Mogilner A, Obeso JA, Kaplitt MG. Safety and efficacy of staged, bilateral magnetic resonance-guided focused ultrasound pallidothalamic tractotomy for motor complications of Parkinson's disease: a prospective, multicentre, single-arm trial. Lancet Neurol. 2026 Jul;25(7):654-663. doi: 10.1016/S1474-4422(26)00142-0.
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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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate 4000 in people with Parkinson Disease, run by InSightec at 9 sites in 3 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 6 inclusion and 29 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain, Taiwan. 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?
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?
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication (time frame: Up to Month 3 post Bilateral 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 NCT04728295, 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 17 Feb 2025.