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Parkinson DiseaseNCT06584383

A 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

A study testing Exablate MRgFUS subthalamotomy and Best Medical Treatment in people with Parkinson Disease, run by InSightec at 4 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Parkinson Disease
What is being tested?
Exablate MRgFUS subthalamotomy and Best Medical Treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
4 sitesin 3 countries
Study dates
1 Aug 2024to Sep 2029
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women; age 30 to 65 years old
  • Subjects who are able and willing to give consent and able to attend all study visits. - Subjects with a diagnosis of PD according to the modified clinical criteria by the Movement Disorders Society, for less than 5 years and more than 12 months.
  • Off-medication MDS-UPDRS part III of the most affected body side ≥ 10
  • Motor signs predominantly present in one body side: Asymmetry index (MDS-UPDRS III of the most affected side/MDS-UPDRS III of the least effected side) ≥ 2.
  • Patients should have a stable pharmacological regime for the last 4-weeks prior to baseline evaluation.
  • Topographic coordinates of the subthalamic nucleus are localizable on MRI so that it can be targeted by the Exablate device.
  • Skull density ratio (SDR) score of 0.40 or higher*. The SDR is a determinant factor for the suitability to MRgFUS ablation. SDR is a ratio of ultrasound energy penetration through the skull. The SDR threshold for using Exablate 4000 is established at 0.4 with patients having SDR below that value considered unsuitable candidates.
  • Able to communicate sensations during the Exablate MRgFUS treatment.

Who cannot join

  • MDS-UPDRS part III OFF medications > 32 in the off state and/or Hoehn and Yahr state ON medication greater than 2.
  • Significative evidence (by clinical history) of having developed features indicative of PD motor onset 2 or more years prior to formal diagnosis.
  • Presence of clinically relevant levodopa-induced dyskinesia and/or motor fluctuations as noted by a score > 1 on questions 4.2 or 4.4 of the MDS-UPDRS, that assess disability resulting from motor complications.
  • Levodopa daily dose higher than 500mg or 750 levodopa-equivalents daily.
  • Presence of any symptoms or signs suggesting other central neurodegenerative disease such as multisystem atrophy, progressive supranuclear palsy, cortico-basal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
  • Any suspicion that parkinsonian symptoms are a side effect attributable to intake of neuroleptic or other medications.
Show all 41Show fewer
  • Subjects who have had deep brain stimulation or a prior stereotactic ablation for the treatment of movement disorders.
  • Presence of significant cognitive impairment measured by standard of care method at the center.
  • Patients with clinically relevant co-morbidity such as severe hypertension, diabetes, cardiac, metabolic, and psychiatric conditions
  • Other exclusion criteria for the Exablate system.
  • 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 <30mL/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.
  • Subject who weighs 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 malignant brain tumors.
  • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
  • 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.
  • Patients without clinically relevant parkinsonism in the off- state as evaluated by two examining neurologists (or MDS- UPDRS III in the most affected side <10).

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Spain2 sites

  • HM CINAC- Hospital Universitario HM Puerta del Sur

    Móstoles, 28938

  • Clinica Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

Chile1 site

  • Pontificia Universidad Catolica de Chile

    Santiago

Other trials in Chile

Germany1 site

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

    Kiel, 24105

Other trials in Germany

About this study

Official title: Early Focus II: A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound (MRgFUS) Subthalamotomy in Patients With Early-Stage Parkinson's Disease (ESPD)

This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment.

Read the detailed description

This is a prospective, randomized (ratio 2:1), multicenter study to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment. Patients assigned to the treatment arm will receive unilateral Exablate MRgFUS subthalamotomy. Patients assigned to control group will receive best medical treatment.

Being tested
Exablate MRgFUS subthalamotomy, Best Medical Treatment
Keywords
Exablate, MRgFUS, Subthalamotomy
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 MRgFUS subthalamotomyProcedure or surgery

    Exablate MRgFUS subthalamotomy for Parkinson's Disease

  • Best Medical TreatmentDrug

    Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease

Study groups in NCT06584383
Study groupRoleWhat they receive
Exablate ArmExperimentalSubjects will receive Exablate MRgFUS subthalamotomy
Receives: Procedure: Exablate MRgFUS subthalamotomy
Control ArmActive comparatorSubjects will receive best medical treatment. If patients from the control arm undergo the unilateral Exablate MRgFUS subthalamotomy between month 12 to 36, they will be exiting the study.
Receives: Procedure: Exablate MRgFUS subthalamotomy; Drug: Best Medical Treatment
Reference ArmActive comparatorPatients fulfilling all inclusion/exclusion criteria except for the SDR requirements (and so anatomically not able to undergo MRgFUS subthalamotomy) will be offered the option to receive best medical treatment and will be formally followed as a reference comparator for up to 3 years.
Receives: Drug: Best Medical Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MDS-UPDRS Part III OFF Medication

    Between-group difference (Exablate and control) in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at 12 months in the off-medication state.

    Measured: 12 Months

Secondary outcomes (9)

  1. PD-specific spatial covariance patterns (PDRP or PD related metabolic pattern) with brain 18F-fluorodeoxyglucose- Positron emission tomography

    The metabolic pattern will be quantified to obtain a PDRP expression scores at baseline, 12-month and to compare disease evolution between groups.

    Measured: 12 Months

  2. MDS-UPDRS III OFF-med video-based evaluation

    Between group comparison (Exablate and control) through month 12 and within group comparison vs baseline month 12 in MDS-UPDRS III OFF-med video-based evaluation by a blinded movement disorders neurologist (only at baseline and 12 months).

    Measured: 12 Months

  3. MDS-UPDRS I, II, III (ON and OFF meds) and UPDRS IV

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in MDS-UPDRS I, II, III (ON and OFF meds) and UPDRS IV.

    Measured: 12 Months, 24 Months, 36 Months

  4. MDS Unified Dyskinesia Rating Scale

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in MDS Unified Dyskinesia Rating Scale.

    Measured: 12 Months, 24 Months, 36 Months

  5. Quality of life assessment (PDQ39)

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Quality-of-life assessment (PDQ39).

    Measured: 12 Months, 24 Months, 36 Months

  6. Levodopa equivalent dose change usage (milligrams)

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Levodopa equivalent dose usage (milligrams).

    Measured: 12 Months, 24 Months, 36 Months

  7. MDS-Non motor rating scale

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in MDS-Non motor rating scale.

    Measured: 12 Months, 24 Months, 36 Months

  8. Patient Global Impression of Change (PGIC)

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Patient Global Impression of Change (PGIC).

    Measured: 12 Months, 24 Months, 36 Months

  9. Clinician Global Impression of Change (CGIC)

    Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Clinician Global Impression of Change (CGIC).

    Measured: 12 Months, 24 Months, 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start1 Aug 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
Parallel groups
Model description
If patients from the control arm undergo the unilateral Exablate MRgFUS subthalamotomy between month 12 to 36, they will be exiting the study.
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06584383
Sponsor's protocol ID
PD017
Status last verified
May 2026
First submitted
30 Aug 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exablate MRgFUS subthalamotomy and Best Medical Treatment in people with Parkinson Disease, run by InSightec at 4 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 8 inclusion and 41 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain, Chile, Germany. 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-UPDRS Part III OFF Medication (time frame: 12 Months). 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 NCT06584383.

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 6 May 2026.

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