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

Status: Terminated
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 74
Healthy Volunteers: No
View:

• 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

Locations
United States
New York
NYU Medical Center
New York
Time Frame
Start Date: July 2014
Completion Date: September 2017
Participants
Target number of participants: 4
Treatments
GK subthalamotomy
Evaluate the safety and efficacy of unilateral GK subthalamotomy for PD in patients deemed poor candidates for DBS.
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov

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