A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
Phase 4
Completed
- Conditions
- Dystonia
- Registration Number
- NCT02263417
- Lead Sponsor
- Beijing Pins Medical Co., Ltd
- Brief Summary
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.
- Detailed Description
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Subject is aged 18 to 75 years old, male or female.
- Diagnosed with cervical dystonia by a movement disorders neurologist.
- Has cervical dystonia alone, not generalized or multifocal.
- Has had adequate trials of medical therapy.
Exclusion Criteria
- Cognitive impairment.
- Abnormalities on pre-operative magnetic resonance imaging (MRI).
- Medical conditions precluding general anaesthetic or surgery.
- Unstable psychiatric disease.
- Previous brain lesions to treat cervical dystonia.
- Attended some other trials within three month.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Burke-Fahn-Marsden Scale (BFM) Change from baseline in BMF at 1, 3 months and 6 months
- Secondary Outcome Measures
Name Time Method Quality of life (SF-36) Change from baseline in SF-36 at 1, 3 months and 6 months Psychiatric assessment (HADS-D and PANSS) Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
Trial Locations
- Locations (1)
Peking union medical college hospital
🇨🇳Beijing, Beijing, China
Peking union medical college hospital🇨🇳Beijing, Beijing, China