Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT02249559
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
74 Years
Study:
NCT02249559
Study Brief:
Protocol Section:
NCT02249559