Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorZhang Jianguo

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

86 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zhang Jianguo

Lead sponsor

Beijing Municipal Administration of Hospitals

Sponsor institution