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A Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

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ClinicalTrials.gov Identifier: NCT03454425
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Exablate Subthalamotomy Device: Sham Exablate Subthalamotomy Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exablate Subthalamotomy
Exablate treatment for Parkinson's Disease Motor Features
Device: Exablate Subthalamotomy
ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Other Names:
  • MRgFUS
  • Subthalamotomy

Sham Comparator: Sham ExAblate Subthalamotomy Device: Sham Exablate Subthalamotomy
Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features




Primary Outcome Measures :
  1. Efficacy - MDS-UPDRS [ Time Frame: Baseline to 4 months post treatment ]
    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

  2. Safety - Adverse Events [ Time Frame: Baseline to 4 Months post treatment ]
    To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.


Secondary Outcome Measures :
  1. MDS-UPDRS [ Time Frame: Baseline to Month 4 post treatment ]
    Mean change in the motor MDS-UPDRS score for the treated/allegedly treated body side in the on-medication condition (when applicable). - Mean change in specific PD motor features (i.e, tremor, rigidity and akinesia according to MDS-UPDRS III subscores in the contralateral body side). - Mean change in the motor MDS-UPDRS. MDS-UPDRS II. - Mean change in the motor MDS-UPDRS score for the treated/allegedly treated body side off-medication in a video-based examination by an external and blinded Movement Disorders neurologist. - Achievement of minimal clinical relevant reduction of the MDS-UPDRS III (as according to the literature) for the treated body side in the "treatment arm" at 4 months (intragroup Baseline to 4-months comparison) in the off-medication condition.

  2. MDS-UPDRS [ Time Frame: Baseline to Month 12 post treatment ]
    Durability of the reduction in the contralateral motor MDS-UPDRS at 12 months in the treated group could also be considered.

  3. UPDRS IV [ Time Frame: Baseline to Month 12 post treatment ]
  4. Quality of life assessment with the PDQ39 [ Time Frame: Baseline to Month 12 post treatment ]
  5. Levodopa equivalent medication change usage (milligrams) [ Time Frame: Baseline to Month 12 post treatment ]
  6. Patient global impression of change [ Time Frame: Baseline to Month 4 post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women age 30 years or older
  2. Subjects who are able and willing to give consent and able to attend all study visits.
  3. Subjects with a diagnosis of PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
  4. Predominant motor features/disability from one side of the body (i.e asymmetry index > 1.5) as determined by a movement disorders neurologist.
  5. Motor clinical features non-optimally controlled by an adequate medical treatment 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.
  6. No major changes in pharmacological regime for PD should be done for the 30 days prior to procedure.
  7. Topographic coordinates of the subthalamic nucleus are localizable on MRI so that it can be targeted by the ExAblate device.
  8. Able to communicate sensations during the ExAblate MRgFUS treatment Inclusion and exclusion criteria have been agreed upon by two members of the medical team

Exclusion Criteria:

  1. Hoehn and Yahr stage in the ON medication state of 2.5 or greater
  2. Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS.
  3. 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.
  4. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
  5. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
  6. Presence of significant cognitive impairment defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or Mattis Dementia Rating Scale of 120 or lower.
  7. 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
  8. 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.
  9. Legal incapacity or limited legal capacity as determined by the neuropsychologist
  10. 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
  11. Subjects with unstable cardiac status including
  12. Severe hypertension (diastolic BP > 100 on medication).
  13. History of or current medical condition resulting in abnormal bleeding and/or coagulopathy.
  14. 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
  15. 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
  16. 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;
  17. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  18. Significant claustrophobia that cannot be managed with mild medication.
  19. Subject who weight more than the upper weight limit of the MR table and who cannot fit into the MR scanner
  20. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
  21. History of intracranial hemorrhage
  22. History of multiple strokes, or a stroke within past 6 months
  23. Subjects with a history of seizures within the past year
  24. Subjects with malignant brain tumors
  25. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
  26. Any illness that in the investigator's opinion preclude participation in this study.
  27. Subjects unable to communicate with the investigator and staff.
  28. Pregnancy or lactation.
  29. Subjects who have an Overall Skull Density Ratio lower than 0.35 as calculated from the screening CT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454425


Contacts
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Contact: Brian Ostrander 214.630.2000 briano@insightec.com

Locations
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Spain
Hospital Universitario HM Puerta Del Sur. CINAC Recruiting
Móstoles, Madrid, Spain, 28938
Contact: Raul Martinez, MD    912673201    consulta.hmcinac@hmhospitales.com   
Principal Investigator: Jose Obeso, MD         
Sponsors and Collaborators
InSightec

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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03454425     History of Changes
Other Study ID Numbers: PD010
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InSightec:
Parkinson's Disease
ExAblate
MRgFUS
Sub-Thalamotomy

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases