Parkinson's DiseaseNCT02246374
ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease
A study testing ExAblate Transcranial System in people with Parkinson's Disease, run by InSightec at 1 site in United States.
Trial summary
This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ExAblate Transcranial System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 18 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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 sub-scale in the ON vs OFF medication state
- Disabling motor clinical features not optimally controlled by an adequate medication prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated
- Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon
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- Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
- Subthalamic nucleus is visible on MRI so that it can be targeted by the ExAblate device
- Subjects should have a Screening motor assessment of ≥ 35 while OFF medications on the MDS-UPDRS
- Subject is able to communicate sensations during the ExAblate Transcranial procedure
Who cannot join
- Hoehn and Yahr stage in the ON medication state of 2.5 or greater
- Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS
- 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 defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or Mattis Dementia Rating Scale of 120 or lower
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- Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
- Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory
- Legal incapacity or limited legal capacity as determined by the neuropsychologist
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within the preceding 12 month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household)
- Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
- Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights)
- Subjects with unstable cardiac status including:
- Unstable angina pectoris on medication
- Subjects with documented myocardial infarction within six months of protocol entry
- Significant congestive heart failure defined with ejection fraction < 40
- Subjects with unstable ventricular arrhythmias
- Subjects with atrial arrhythmias that are not rate-controlled
- Severe hypertension (diastolic BP > 100 on medication)
- History of or 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 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 standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Significant claustrophobia that cannot be managed with mild medication
- Subjects who weigh more than the upper weight limit of the MR 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
- History of 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
- Any illness that in the investigator's opinion preclude participation in this study
- Subjects unable to communicate with the investigator and staff
- Pregnancy or lactation
- Subjects who have an overall Skull Density Ration lower than 0.40 as calculated from the screening CT
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Randomized Feasibility Clinical Trial of the Management of the Medically-Refractory Motor Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Subthalamic Nucleus Using the ExAblate Transcranial System
This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.
Read the detailed description
This study is designed as a prospective, randomized, double-blind (to subjects and examiners), two-arm (ExAblate treated arm vs ExAblate Sham treated control arm) feasibility study. All treated subjects will be followed for 12 months.
Data will be collected to establish the basic safety and clinical efficacy of this type of treatment as the basis for later studies that will evaluate the full clinical efficacy.
- Conditions
- Parkinson's Disease
- Being tested
- ExAblate Transcranial System
- Keywords
- Parkinson's Disease, ExAblate, MRgFUS
- 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 Transcranial SystemDevice
Also called MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound
ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Treated Arm | Experimental | ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease. Receives: Device: ExAblate Transcranial System |
| ExAblate Sham Treated Arm | Sham comparator | ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy. Receives: Device: ExAblate Transcranial System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Safety will evaluate the incidence and severity of adverse events associated with ExAblate subthalamotomy for the treatment of Parkinson's Disease motor features.
Measured: Baseline to 4 months post treatment
Mean Change in MDS-UPDRS Part III Scores
This is a feasibility trial with no hypothesis testing. Primary efficacy will be evaluated using basic summary statistics including comparison of between- and within-group differences in the mean change (from baseline to 4 months) of the motor MDS-UPDRS Part III score for the side contralateral to subthalamotomy in the off-medication condition. For the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination), the scores range from a minimum of 0 (no motor symptoms) to a maximum of 132 (severe motor impairment). The Minimal Clinically Important Difference (MCID) for MDS-UPDRS Part III (Motor Examination) generally ranges from 3.25 to 5 points for improvement.
Measured: Baseline to 4 months post treatment
Secondary outcomes (1)
Long Term Adverse Events Profile
Additional safety will be evaluated by follow up of adverse events through 12 months post treatment.
Measured: Baseline to 12- months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Elias, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246374
- Sponsor's protocol ID
- PD003
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2014
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Clinical Trial of the Management of the Medically-Refractory Motor Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Subthalamic Nucleus Using the ExAblate Transcranial System
- ClinicalTrials.gov ID
- NCT02246374
- Acronym / sponsor ID
- PD003
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, ExAblate, MRgFUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.
Detailed description
This study is designed as a prospective, randomized, double-blind (to subjects and examiners), two-arm (ExAblate treated arm vs ExAblate Sham treated control arm) feasibility study. All treated subjects will be followed for 12 months.
Data will be collected to establish the basic safety and clinical efficacy of this type of treatment as the basis for later studies that will evaluate the full clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ExAblate Treated Arm | Experimental | Device: ExAblate Transcranial SystemExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease. |
| ExAblate Sham Treated Arm | Sham comparator | Device: ExAblate Transcranial SystemExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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
- 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 sub-scale in the ON vs OFF medication state
- Disabling motor clinical features not optimally controlled by an adequate medication prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated
Key exclusion criteria (39 listed)
- Hoehn and Yahr stage in the ON medication state of 2.5 or greater
- Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS
- 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
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 Transcranial SystemAlso: MRgFUS, FUS, Focused Ultrasound, MR Guided Focused UltrasoundExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease | Device | ExAblate Sham Treated Arm, ExAblate Treated Arm |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: Baseline to 4 months post treatment
Safety will evaluate the incidence and severity of adverse events associated with ExAblate subthalamotomy for the treatment of Parkinson's Disease motor features.
Mean Change in MDS-UPDRS Part III Scores
Time frame: Baseline to 4 months post treatment
This is a feasibility trial with no hypothesis testing. Primary efficacy will be evaluated using basic summary statistics including comparison of between- and within-group differences in the mean change (from baseline to 4 months) of the motor MDS-UPDRS Part III score for the side contralateral to subthalamotomy in the off-medication condition. For the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination), the scores range from a minimum of 0 (no motor symptoms) to a maximum of 132 (severe motor impairment). The Minimal Clinically Important Difference (MCID) for MDS-UPDRS Part III (Motor Examination) generally ranges from 3.25 to 5 points for improvement.
1 secondary outcome
Long Term Adverse Events Profile
Time frame: Baseline to 12- months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeff Elias, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate Transcranial System in people with Parkinson's Disease, run by InSightec at 1 site in United States.
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 10 inclusion and 39 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence and Severity of Adverse Events (time frame: Baseline to 4 months post treatment). The study lists 2 primary outcomes in all. 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 13 Aug 2026.