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NCT01076452 · ClinicalTrials.gov registry record · Phase 3
Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 299
- Enrollment target
NCT01076452: Completed Phase 3 study, sponsored by US Department of Veterans Affairs.
NCT01076452 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 299 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01076452, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 299 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately fo
Interventions
- DEVICE Bilateral Deep Brain Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2002-04 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT01076452 record still lists
NCT01076452 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Bilateral Deep Brain Stimulation is the first listed.
NCT01076452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01076452 about?
NCT01076452 is a clinical study titled "Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial". 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.
What is the current status of trial NCT01076452?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2002-04. Estimated completion is 2009-04.
What interventions are being tested in trial NCT01076452?
The interventions under investigation include: Bilateral Deep Brain Stimulation (DEVICE).
Who is sponsoring clinical trial NCT01076452?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01076452's enrollment target sits among peer trials
299 1161st of 2000 higher than 839 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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