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Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)

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ClinicalTrials.gov Identifier: NCT04728295
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Exablate 4000 Not Applicable

Detailed Description:

This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 8 sites.

Subjects will undergo an Exablate index procedure targeting the PTT and will be seen at 1-week,1-, 3-, and 6- months post treatment. At the 6-month visit, subjects will be evaluated for an Exablate procedure on the other side.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: This is a bilateral study. Subjects will be treated on one side of the brain and will be allowed to receive treatment on the other side if eligible.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exablate Pallidothalamic Tractotomy
Exablate treatment for Advanced Idiopathic Parkinson's Disease
Device: Exablate 4000
Exablate Pallidothalamic Tractotomy
Other Name: MRgFUS




Primary Outcome Measures :
  1. MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication [ Time Frame: Up to Month 3 post Bilateral Treatment ]
    OFF-medication, Upper + Lower Extremity motor score from the MDS-UPDRS Part III comparing Month 3 post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.


Secondary Outcome Measures :
  1. MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part II [ Time Frame: Up to Month 12 post Bilateral Treatment ]
    MDS-UPDRS Part II - Activities of Daily living comparing all Bilateral scheduled visits to Baseline. Lower score on the scale means a better outcome.


Other Outcome Measures:
  1. MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication [ Time Frame: Up to Month 12 post Bilateral Treatment ]
    OFF-medication, Upper + Lower Extremity motor score from the MDS-UPDRS Part III comparing all visits post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.

  2. MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part IV [ Time Frame: Up to Month 12 post Bilateral Treatment ]
    MDS-UPDRS Part IV at all Bilateral visits comparing all visits post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.



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 and older, desiring bilateral treatment option with second side staged at 6 months.
  2. Subject is able and willing to give informed consent and able to attend all study visits
  3. Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
  4. Subject has Levodopa responsive as defined by at least a 30% reduction in MDSUPDRS motor subscale in the ON vs OFF medication state.
  5. Subject has MDS-UPDRS score of 30 or greater in the meds OFF condition.
  6. Motor complications of PD on optimum medical treatment characterized dyskinesia (MDS-UPDRS item 4.2 score of 2 or greater in the meds ON condition) OR Motor fluctuations (MDS-UPDRS item 4.4 score of 2 or greater in the meds ON condition)
  7. Subject is on a stable dose of all PD medications for 30 days prior to screening visit PD assessments as determined by medical records
  8. Subject is able to communicate sensations during the Exablate procedure.
  9. Subject's Pallido-thalamic region can be targeted by the Exablate device.

Exclusion Criteria:

  1. Subject has a score of 3 or greater on the PULL test.
  2. Subject with severe premorbid risks as specified in the MDS-UPDRS Part II subsection motor aspects of experiences of daily living scores: 3 or 4 on question 2.1 (speech) OR 3 or 4 on question 2.3 (chewing and swallowing) OR 4 on question 2.2 (saliva and drooling).
  3. Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
  4. Subject with significant cognitive impairment as determined by the neuropsychologist.
  5. Subject has 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.
  6. Subject with unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation
  7. Women of childbearing potential who are pregnant or lactating
  8. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
  9. Subject with unstable cardiac status or severe hypertension including:

    • Documented myocardial infarction within six months of enrollment
    • Unstable angina on medication
    • Unstable or worsening congestive heart failure
    • Left ventricular ejection fraction below the lower limit of normal
    • History of a hemodynamically unstable cardiac arrhythmia
    • Cardiac pacemaker
    • Diastolic BP > 100 on medication
  10. Subject with history of abnormal bleeding, hemorrhage, or coagulopathy including:

    • Subject 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.
    • History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months
    • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
  11. Subject is 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.
  12. Subject 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.
  13. Subjects with a history of seizures within the past year.
  14. Subject with an intracranial brain tumor
  15. Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, liver failure, blood dyscrasias, etc.
  16. Any illness that in the investigator's opinion preclude participation in this study.
  17. Subject with standard contraindications for MR imaging such as implanted metallic devices
  18. Subject who had prior deep brain stimulation of the basal ganglia or thalamus.
  19. Subjects who are unable to tolerate the required prolonged stationary supine position during treatment.
  20. Subjects who have an Overall Skull Density Ratio of less than 0.40 as calculated from the screening CT.
  21. Subject who is participating in another clinical investigation with an active treatment arm in the last 30 days.
  22. Subject who is unable to communicate with the investigator and staff. Additional Exclusion Criteria for Staged Bilateral PTT procedure
  23. Subject who had moderate to severe neurological event such as dysphagia, speech, gait imbalance, cognitive impairment, and visual field deficit following index procedure.

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): NCT04728295


Contacts
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Contact: Gaganjot Sooch 214-630-2000 gaganjots@insightec.com

Sponsors and Collaborators
InSightec
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT04728295    
Other Study ID Numbers: PD014
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by InSightec:
Exablate
MRgFUS
Pallidothalamic Tract
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