Phase 3
Completed N=255
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
Source: ClinicalTrials.gov NCT00056563 ↗Enrolled (actual)
255
Serious AEs
25.1%
Results posted
Jul 2013
Primary outcomePrimary: The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. — 4.6; 0 Hours per day
Summary
The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving Parkinson's disease symptoms
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. |
4.6; 0 | — |
| SECONDARY The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation |
-12.3; -1.7 | — |
Eligibility Criteria
Inclusion Criteria
- idiopathic Parkinson's disease,
- Hoehn and Yahr stage 2 or worse "off" medications,
- L-dopa responsive but with persistent disabling symptoms (i.e., refractory to "best medical treatment" with motor fluctuations, dyskinesias),
- on stable medical therapy for at least one month prior to enrollment,
- age > 21,
- available and willing to be followed-up according to study protocol, and
- no intracranial abnormalities that would contraindicate surgery (based on pre-operative magnetic resonance imaging of the brain).
Exclusion Criteria
- "Parkinson's plus" syndromes,
- medical contraindications to surgery or stimulation,
- active alcohol or drug abuse,
- score on minimental status exam 24 or lower, or other neuropsychological dysfunction (e.g., dementia) that would contraindicate surgery,
- concurrent participation in another research protocol.
Data sourced from ClinicalTrials.gov (NCT00056563). 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.