N/A
Completed N=7
Pilot Study for Automated Deep Brain Stimulation Programming
Parkinson's Disease · Tremor · Bradykinesia
Source: ClinicalTrials.gov NCT02046863 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming — -35.7 Percentage change
Summary
The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming |
-35.7 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of idiopathic Parkinson's disease
- Implanted deep brain stimulation system awaiting initial programming session
Exclusion Criteria
- Subjects with significant psychiatric illness or dementia
- Significant cognitive impairment
Data sourced from ClinicalTrials.gov (NCT02046863). 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.