Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease
Status: | Terminated |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 74 - Any |
Updated: | 12/8/2017 |
Start Date: | July 2014 |
End Date: | September 2017 |
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.
subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain
stimulation.
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.
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.
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.
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