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Subthalamotomy by ExAblate Transcranial System to Treat Motor Features of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02912871
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : January 31, 2017
Sponsor:
Collaborator:
Insightech
Information provided by (Responsible Party):
Fundación de investigación HM

Brief Summary:
Based on published animal and human studies, ExAblate Transcranial subthalamotomy can be as safe and as effective as any of the surgical treatments within the currently accepted standard of care including radiofrequency lesioning and Deep Brain Stimulation (DBS). A unilateral lesion of the subthalamic nucleus has shown reduction of contralateral motor symptoms in Parkinson's disease (PD). Using ExAblate Transcranial Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) to create the subthalamotomy has several potential advantages over current therapies including the fact that transcranial lesioning can be performed in a precise manner with simultaneous as well as continuous clinical and radiographic monitoring. If the potential of ExAblate Transcranial subthalamotomy can be realized, it could supplant radiofrequency and radiosurgery techniques and provide a viable alternative procedure for subjects considering DBS.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: MRIgHIFU unilateral subthalamotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of the Feasibility, Safety and Efficacy of Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
Study Start Date : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRIgHIFU unilateral subthalamotomy
Unilateral Subthalamotomy performed by MRI guided High intensity focused ultrasound in a single session.
Other: MRIgHIFU unilateral subthalamotomy
High Intensity focused ultrasound unilateral subthalamotomy: Unilateral thermolesion in the Subthalamic nucleus performed by High Intensity Focused ultrasound




Primary Outcome Measures :
  1. All causes of morbidity [ Time Frame: within the first 6 months (plus minus 1 month) after treatment ]
    Number of treatment-related adverse events as assessed by CTCAE v4.0

  2. Efficacy [ Time Frame: 6 months ]
    Improvement in the score of the Movement Disorders Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) that evaluates motor features of PD. The scale will be assessed pretreatment and after intervention and the reduction after treatment in the total MDS-UPDRS III score and the score in the treated hemibody will be measured. MDS-UPDRS III is a scale that assesses all the motor features of PD (akinesia, tremor, rigidity, gait disturbance). Score range between 0 (no presence of motor features) and 132 (maximum score for all items).


Secondary Outcome Measures :
  1. MDS-UPDRS I [ Time Frame: 6 months ]
    MDS-UPDRS I evaluates non-motor symptoms of PD. Scores of the scales will be measured pretreatment and after procedure and compared.

  2. MDS-UPDRS II [ Time Frame: 6 months ]
    MDS-UPDRS II evaluates dependence in daily life activities. Scores of the scales will be measured pretreatment and after procedure and compared.

  3. MDS-UPDRS IV [ Time Frame: 6 months ]

    MDS-UPDRS IV evaluates presence and impact of motor complications (i.e. motor fluctuations and dyskinesia).

    Scores of the scales will be measured pretreatment and after procedure and compared.


  4. Dyskinesia severity as assessed through the Dyskinesia rating scale [ Time Frame: 6 months ]
    Dyskinesia rating scale assesses the presence of involuntary movements

  5. Levodopa equivalent medication usage (milligrams) when applicable [ Time Frame: 6 months ]
  6. Patient and Clinician Global Impression of Change [ Time Frame: 6 months ]
  7. Quality of life assessment with PDQ-39 [ Time Frame: 6 months ]


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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
  2. Subjects who are able and willing to give informed consent and able to attend all study visits through 6 Months
  3. Subjects with a diagnosis of PD by United Kingdom Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
  4. Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by a movement disorders neurologist
  5. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry, if possible.
  6. Topographic coordinates of the subthalamic nucleus are localizable on Magnetic resonance imaging (MRI) so that it can be targeted by the ExAblate device.
  7. Subject is able to communicate sensations during the ExAblate Transcranial procedure.

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 Movement Disorders Society-Unified Parkinson's Disease Rating Scale (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 Diagnostic and Statistical Manual of Mental Disorders-IV (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).
  11. 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
  12. Severe hypertension (diastolic Blood Pressure > 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 international normalized ratio (INR) coagulation studies exceeding the institution's laboratory standard
  16. Patient with severely impaired renal function with estimated glomerular filtration rate <30milliliter/minute/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis;
  17. Subjects with standard contraindications for MRI 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 weigh more than the upper weight limit of the MRI table and who cannot fit into the MRI 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 (SDR) of 0.3 (±0.05) or less as calculated from the screening Cranial Tomography scan (CT).

    • It should be noted that for those candidates whose SDR ratio score is within the standard deviation, full technical assessment should be performed and reviewed by study investigator with the support of the sponsor.

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): NCT02912871


Sponsors and Collaborators
Fundación de investigación HM
Insightech
Investigators
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Principal Investigator: Jose Obeso, MD, PhD CINAC, HM Puerta del Sur. Avda. Carlos V nº 70. CP 28938. Móstoles MADRID (SPAIN) Tel: +34 91 2673201; Email: consulta.hmcinac@hmhospitales.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT02912871    
Other Study ID Numbers: PD003E
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundación de investigación HM:
subthalamotomy
motor features
deep brain stimulation
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