Phase 3
Completed N=299
Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial
Source: ClinicalTrials.gov NCT01076452 ↗Enrolled (actual)
299
Serious AEs
53.5%
Results posted
Jan 2014
Primary outcomePrimary: The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication. — -12.9; -13.1 units on a scale
Summary
The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication. |
-12.9; -13.1 | — |
| SECONDARY The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months. |
0.6; 0.4 | — |
| SECONDARY The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months. |
-2.3; -3.4 | — |
| SECONDARY The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months. |
-3.9; -3.4 | — |
Eligibility Criteria
Inclusion Criteria
- idiopathic Parkinson's Disease
- Hoehn and Yahr stage 2 or worse when off medications
- L-dopa responsive with clearly defined "on" periods (i.e. symptoms improve at least partially with L-dopa administration, a characteristic that helps distinguish idiopathic PD from "Parkinson's Plus" and atypical Parkinson's syndromes-see below)
- persistent disabling symptoms (e.g. on troubling dyskinesias, or disabling "off" periods at least 3 hours/day) despite medication therapy. Patients will have been treated with variable doses of levodopa and dopamine agonists (at a minimum) and will have had an adequate trial of other adjunctive medications)
- stable on medical therapy for at least one month prior to study enrollment
- age >21
- available and willing to be followed-up according to study protocol
Exclusion Criteria
- "Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
- previous Parkinson's Disease surgery
- medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
- contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
- active alcohol or drug abuse
- score on Mini-Mental Status examination of 24 or lower, or other neuropsychological dysfunction 9e.g. dementia) that would contraindicate surgery
- intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)
- pregnancy
- concurrent participation in another research protocol
Data sourced from ClinicalTrials.gov (NCT01076452). 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.