Trials / Completed
CompletedNCT04255719
Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD
Unilateral Pallidal vs Unilateral Subthalamic Nucleus Deep Brain Stimulation in the Same Patient With Parkinson Disease: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- All
- Age
- 55 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients. In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | DBS | Unilateral DBS for treatment of patients with PD |
Timeline
- Start date
- 2020-03-01
- Primary completion
- 2021-02-27
- Completion
- 2021-03-02
- First posted
- 2020-02-05
- Last updated
- 2021-03-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04255719. Inclusion in this directory is not an endorsement.