Status:
COMPLETED
A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Dystonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02263417
Start Date
July 1 2015
End Date
June 1 2020
Last Update
March 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking union medical college hospital
Beijing, Beijing Municipality, China, 100032