N/A
Completed N=12
Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
Source: ClinicalTrials.gov NCT02835274 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase — 21; 21; 13; 16 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase |
21; 21; 13; 16 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02835274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.