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Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease (GKSTN)

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ClinicalTrials.gov Identifier: NCT02249559
Recruitment Status : Terminated
First Posted : September 25, 2014
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain stimulation.

Condition or disease
Parkinsons Disease

Detailed Description:

The goal of the study is to enroll 20 subjects who could benefit from unilateral subthalamotomy due to the presence of unilateral rigidity, tremor, bradykinesia and/or dyskinesias (as opposed to axial symptoms such as walking) but who are suboptimal candidates for deep brain stimulation (DBS) because of advanced age (>74), medical comorbidities precluding surgery, or patient aversion to DBS, and who show more than 30% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) score in the ON versus OFF medication state.

Secondary objectives will focus on the efficacy of Gamma Knife (GK) subthalamotomy for Parkinson's disease (PD), as determined by changes in the patient's clinical status and any improvement following the treatment. A full neurologic exam as well as a screen for depression will be administered at every postoperative visit. The patient's neurologic function will be assessed with a full neurological examination and objectively quantified using the UPDRS focusing on the contralateral side, as well as overall UPDRS.

The clinician will complete a Clinical Global Impression (CGI) and Mini-Mental State Examination (MMSE) at each visit to record overall impression of the patient's disease progression and severity, and to evaluate cognitive function. Pre- and post-treatment assessment of the Levodopa Equivalent Daily Dose (LEDD) (quantification of medication regimen in levodopa equivalents) will be obtained and recorded to evaluated the efficacy of gamma knife subthalamotomy (GKS) as a treatment for Parkinson's disease (PD). A Parkinson's Disease Questionnaire-39 (PDQ-39) to determine the patient's independence and quality of life will be filled out at each visit. Finally, the patient will complete a Beck Depression Inventory at each clinic visit to monitor for development or progression of depressive symptoms.

Study Design
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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease
Actual Study Start Date : July 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
GK subthalamotomy
Evaluate the safety and efficacy of unilateral GK subthalamotomy for PD in patients deemed poor candidates for DBS.


Outcome Measures
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Primary Outcome Measures :
  1. Safety of performing GK lesions in the Subthalamic Nucleus (STN) for PD patients [ Time Frame: 12 months ]
    • Safety of GK subthalamotomy in the management of PD as measured by stable findings on neurologic exam at each clinic visit (hemiballismus, dyskinesias, sensory changes) and the absence of Serious Adverse Events (SAE) attributable to treatment.
    • Because this study does not have a control group, we will compare the non-inferiority of GK subthalamotomy to published outcomes in PD patients undergoing other forms of management.


Secondary Outcome Measures :
  1. Efficacy of GK subthalamotomy for PD [ Time Frame: 12 months ]

    To be determined by changes in the patient's clinical status and any improvement following the treatment.

    • Neurologic function as determined by UPDRS, MMSE, neurologic exam results, CGI assessment and LEDD score.
    • Quality of life, as determined by PDQ-39 score and Beck's Depression Inventory (BDI) score.


Eligibility Criteria
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Ages Eligible for Study:   74 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  1. Otherwise appropriate DBS candidates but deemed suboptimal for DBS on account of one or more of the following:

    • advanced age greater than 74 years of age

    • medical comorbidities

      • need for continual anticoagulation
      • poor candidates for general anesthesia based on cardiac, hepatic ,renal or pulmonary status
      • high infection risk if internal DBS device hardware is placed (ie. Poor diabetes mellitus control)
    • patient aversion to DBS

  2. Patients with asymmetric disease symptoms including:

    • rigidity
    • tremor
    • bradykinesia
    • dyskinesia

  3. More than 30% improvement in UPDRS score in ON versus OFF medication state, except:

    • in the presence of disabling contralateral dyskinesias/dystonia limiting dose tolerance
    • tremors that are medically refractory
  4. Patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of GKS, as determined by review of medical record
  5. MMSE score greater than or equal to 26

Exclusion Criteria:

  • Patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on Questions 28, 29 & 30 on the UPDRS
  • Patients whose symptoms do not improve by more than 30% in UPDRS score with medication, unless patient experiences dose-limiting side effects
  • The presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
  • Patients who have had prior brain radiation
  • Patients with improvement and satisfactory symptom management will not be offered this procedure. We will only include patients without satisfactory symptom management.
Contacts and Locations
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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): NCT02249559


Locations
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United States, New York
NYU Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Douglas Kondziolka, MD NYU MEDICAL CENTER
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02249559    
Other Study ID Numbers: 14-00902
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
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
Synucleinopathies
Neurodegenerative Diseases