Status:
TERMINATED
Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease
Lead Sponsor:
NYU Langone Health
Conditions:
Parkinsons Disease
Eligibility:
All Genders
74+ years
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.
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...
Eligibility Criteria
Inclusion
- 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
- Patients with asymmetric disease symptoms including:
- rigidity
- tremor
- bradykinesia
- dyskinesia
- 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
- 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
- MMSE score greater than or equal to 26
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02249559
Start Date
July 1 2014
End Date
September 1 2017
Last Update
December 6 2017
Active Locations (1)
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1
NYU Medical Center
New York, New York, United States, 10016