An interventional study of Exablate Subthalamotomy and Sham Exablate Subthalamotomy in Parkinson Disease, sponsored by InSightec. Completed at 1 site in Spain. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by InSightec · Not applicable, Interventional, and Treatment
Among 19 studies in Parkinson Disease by InSightec — 3 open to participants now, 9 under way, none of them phase 3. Parkinson Disease · InSightec.
Among the 19 studies in Parkinson Disease by InSightec, this one is the 5th largest by enrollment of the 16 interventional ones, is one of 3 that started in 2018, is one of 16 with no phase, and was the 8th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →3 of the 19 studies in Parkinson Disease by InSightec are open now, in 4 countries. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 30 Years and older · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2018.
Median enrollment 20 across the 16 interventional studies, 60 across the 3 observational. Of the 10 that completed or were terminated, 3 (30%) have results posted.
InSightec is the lead sponsor of 84 studies on the registry; 9 are open to participants now.
2 of the studies in Parkinson Disease by InSightec that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05565443InSightecMR-guided Focused Ultrasound Plus GCase | 2026-11-01 |
| NCT06584383InSightecA Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease | 2027-09 |
Among the 19 studies in Parkinson Disease by InSightec, from their registry updates:
The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.
A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the treatment of Parkinson's disease motor features.
The objective of this prospective, randomized, double-blind (to subjects, examining neurologists and external video-based examination by Movement Disorders neurologist), two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to confirm the efficacy of ExAblate Model 4000 Type 1 System for the treatment of Parkinson's disease (PD) motor features and to further demonstrate safety.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exablate treatment for Parkinson's Disease Motor Features
Device: Exablate Subthalamotomy
Device: Sham Exablate Subthalamotomy
ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Also known as: MRgFUS, Subthalamotomy
Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Efficacy - MDS-UPDRS
between-group differences in the mean change (from baseline to 4 months) in the motor MDS-UPDRS score for the side contralateral to subthalamotomy (in the treated group) as compared with mean change in the MDS-UPDRS score for the side contralateral to the alleged subthalamotomy (in the sham-procedure group) in the off-medication condition
Time frame: Baseline to 4 months post treatment
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.
Time frame: Baseline to 4 Months post treatment
MDS-UPDRS III ON-medication
MDS-UPDRS III score in the contralateral body side ON-medication condition as measured by the BLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III OFF-medication
MDS-UPDRS III score in the contralateral body side OFF-medication condition as measured by the UNBLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III- Contralateral ON-medication
MDS-UPDRS III score in the contralateral body side ON-medication condition as measured by the UNBLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III
Specific PD motor features sub-scores (rigidity, bradykinesia, tremor) of MDS- UPDRS III in the contralateral body side by visit for the following: OFF and ON-medication condition as measured by the BLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS II
Total score of MDS-UPDRS II
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III Blinded assessor
Total score of MDS-UPDRS III as measured by the BLINDED assessor OFF- and ON-medication
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS IV
Total score of MDS-UPDRS IV and separated by each type of motor complication
Time frame: Baseline to Month 4 post treatment
PDG39
Quality of life assessment with the PDQ39.
Time frame: Baseline to Month 12 post treatment
GIC
Patient global impression of change from Baseline to Month 4 FU.
Time frame: Baseline to Month 4 post treatment
Levodopa
Levodopa equivalent medication change usage (mg).
Time frame: Baseline to Month 12 post treatment
MDS-UPDRS
Durability of the reduction in the contralateral motor MDS-UPDRS at 12 months in the treated group (measured only by the UNBLINDED assessor)
Time frame: Baseline to Month 12 post treatment
MDS-UPDRS
Change in the total MDS-UPDRS III according to disease severity at baseline (as defined by the MDS-UPDRS III score).
Time frame: Baseline to Month 12 post treatment
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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