Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/30/2019 |
| Start Date: | July 19, 2016 |
| End Date: | December 19, 2018 |
Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
The primary objective is to characterize the programming effects of Boston Scientific
Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of
Parkinson's disease in acute and chronic settings.
Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of
Parkinson's disease in acute and chronic settings.
Key Inclusion Criteria:
- Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one
(1) of the following: resting tremor or bradykinesia.
- UPDRS III score of >25 in the meds OFF condition
- Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Key Exclusion Criteria:
- Any significant psychiatric problems, including unrelated clinically significant
depression as determined by the investigator
- Any current drug or alcohol abuse as determined by the investigator
- Any history of recurrent or unprovoked seizures
- Any significant medical condition that is likely to interfere with study procedures or
likely to confound evaluation of study endpoints, including any terminal illness with
survival <12 months
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