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

Stopped early

Conditions studied: Parkinsons Disease

In brief

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.

Key facts

Study ID

NCT02249559

Run by

NYU Langone Health

People needed

4

Starts

2014-07-01

Expected to finish

2017-09-01

Last updated by the study team

2017-12-06

Who can join

Age: 74 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• NYU Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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