Parkinson DiseaseNCT03964272
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
A study testing Exablate Bilateral Subthalamotomy in people with Parkinson Disease and Neurologic Manifestations, run by InSightec at 1 site in Spain.
Trial summary
The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease, Neurologic Manifestations
- What is being tested?
- Exablate Bilateral Subthalamotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jun 2019to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female age 30 years or older
- Able and willing to give consent and able to attend all study visits
- A confirmed diagnosis of Parkinsons Disease
- Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
- Able to localize subthalamic nucleus on MRI for treatment
- Able to communicate sensations during the ExAblate MRgFUS 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 MDS-UPDRS scores
- Presence of other central neurodegenerative disease
- Parkinsonian symptoms are a side effect from neuroleptic medications
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- History of a bleeding disorder or receiving anticoagulant
Show all 13Show fewer
- Subjects with advanced kidney disease or on dialysis
- Subjects with known intolerance or allergies to the MRI contrast agents.
- Presence of unknown or MRI unsafe devices anywhere in the body.
- History of multiple strokes, or a stroke within past 6 months
- Subjects with a history of seizures within the past year
- Subjects with malignant brain tumors
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario HM Puerta Del Sur. CINAC
Móstoles, Madrid, 28938
About this study
Official title: A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features
Read the detailed description
The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.
- Conditions
- Parkinson Disease, Neurologic Manifestations
- Being tested
- Exablate Bilateral Subthalamotomy
- Keywords
- MRgFUS, ExAblate, Parkinsons Disease, Sub-Thalamotomy
- Medical subject headings
- Parkinson Disease, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate Bilateral SubthalamotomyDevice
Also called MRgFUS, Subthalamotomy
Exablate bilateral treatment for Parkinson's Disease Motor Features
| Study group | Role | What they receive |
|---|---|---|
| ExAblate 4000 System | Experimental | Exablate bilateral treatment for Parkinson's Disease Motor Features Receives: Device: Exablate Bilateral Subthalamotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse Events
To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.
Measured: Treatment through 6 month
Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status
Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (reduction from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition
Measured: Treatment through 6 month
Secondary outcomes (4)
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status
- Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)
Measured: Treatment through 6 month
MDS-UPDRS
- Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)
Measured: Treatment through 12 month
MDS-UPDRS (Part I, II and IV)
MDS UPDRS I, II and IV
Measured: Treatment through 6 month
Quality of life assessment
Improved Quality of life assessment with the PDQ39
Measured: Treatment through 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start18 Jun 2019
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul Martinez, MD, Principal investigator, CINAC-Hospital HM Puerta del Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964272
- Sponsor's protocol ID
- PD010B
- Status last verified
- Mar 2026
- First submitted
- 23 May 2019
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03964272
- Acronym / sponsor ID
- PD010B
- Conditions
- Parkinson Disease, Neurologic Manifestations
- Keywords
- MRgFUS, ExAblate, Parkinsons Disease, Sub-Thalamotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 28 May 2019 (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 objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features
Detailed description
The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate 4000 System | Experimental | Device: Exablate Bilateral SubthalamotomyExablate bilateral treatment for Parkinson's Disease Motor Features |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female age 30 years or older
- Able and willing to give consent and able to attend all study visits
- A confirmed diagnosis of Parkinsons Disease
- Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
- Able to localize subthalamic nucleus on MRI for treatment
Key exclusion criteria (13 listed)
- Hoehn and Yahr stage in the ON medication state of 2.5 or greater
- Presence of severe dyskinesia as noted by MDS-UPDRS scores
- Presence of other central neurodegenerative disease
- Parkinsonian symptoms are a side effect from neuroleptic medications
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
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 Bilateral SubthalamotomyAlso: MRgFUS, SubthalamotomyExablate bilateral treatment for Parkinson's Disease Motor Features | Device | ExAblate 4000 System |
Primary outcome
Safety: Adverse Events
Time frame: Treatment through 6 month
To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.
Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status
Time frame: Treatment through 6 month
Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (reduction from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition
4 secondary outcomes
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status
Time frame: Treatment through 6 month
MDS-UPDRS
Time frame: Treatment through 12 month
MDS-UPDRS (Part I, II and IV)
Time frame: Treatment through 6 month
Quality of life assessment
Time frame: Treatment through 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Raul Martinez, MD principal investigator
CINAC-Hospital HM Puerta del Sur
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 Bilateral Subthalamotomy in people with Parkinson Disease and Neurologic Manifestations, run by InSightec at 1 site in Spain.
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 13 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 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 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: Adverse Events (time frame: Treatment through 6 month). 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 20 Mar 2026.