About this trial
The primary objective of this prospective, multicenter, double-blind, randomized, crossover clinical trial is to evaluate whether Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) is more effective than Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) in improving motor symptoms of patients with Parkinson's disease at 90 days post-treatment.
Eligibility criteria
Qualifiers
Age at the time of enrollment: 22-75 years.
Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia
Duration of idiopathic PD: ≥ 5 years.
Severity of PD in the meds off condition: Hoehn-Yahr stages 2.5~ 4.0.
Disqualifiers
Any intracranial abnormalities or medical conditions that Lead to the prohibition of DBS surgery.
Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders).
HAMD score>24.
Any current drug or alcohol abuse, per DSM-IV criteria
Trial design
Treatments tested in this trial
- STN-DBS stimulation
- GPi-DBS stimulation
- STN&GPi-DBS stimulation
Treatment groups
Sponsors and collaborators
Zhang Jianguo
Lead sponsor
Beijing Municipal Administration of Hospitals
Sponsor institution