N/A
Completed N=160
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Source: ClinicalTrials.gov NCT01839396 ↗Enrolled (actual)
160
Serious AEs
11.3%
Results posted
Aug 2018
Primary outcomePrimary: Change in ON Time as Measured by Parkinson's Disease Diary — 3.74; 0.72 hours
Summary
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ON Time as Measured by Parkinson's Disease Diary |
3.74; 0.72 | — |
| SECONDARY Secondary Endpoints |
12.02; 1.19 | — |
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
- Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Key Exclusion Criteria
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
- Any other active implanted devices including neurostimulators and /or drug delivery pumps
- Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Data sourced from ClinicalTrials.gov (NCT01839396). 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.