idiopathic Parkinson's disease
Conditions
Interventions
Treatment group:subthalamic nucleus stimulation
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients with primary PD were eligible for the study if they met the following inclusion criteria: an age of 18 to 70 years; disease durationof 5 years or more; a disease severity rating beyond stage 2 in the off-medication condition, accordingto the Hoehn and Yahr scale, with scores ranging from 0 to 5 and higher scores indicating more severe disease (Hoehn and Yahr, 1967); Scores more than 30 in the off-medication condition as assessed with the use of the (UPDRS-III; scores range from 0 to 108, with higher scores indicating worse functioning); with the improvement of UPDRS-III motor signs of 30% or more with dopaminergic medication (Madopar 250mg). Six hours or more per day spent in the "medication off" state, or with severe dyskinesia, as assessed by means of a dyskinesia diary despite of repeated adjustment of medication. The PD patients can recharge the neurostimulator independently, with favourable compliance and commit to cooperate with the clinical trial study.
Exclusion criteria
Exclusion criteria: Exclusion criteria were major depression with suicidal thoughts (a score of >25 on the Beck Depression Inventory II, 20 with scoresranging from 0 to 63 and higher scores indicating worse functioning), tumor, abnormality in routine liver and renal function, cerebral infarction, hydrocephalus, encephalatrophy, stroke sequela, heart disease, thrombocytopenia, hyperthermalgesia and any medical or psychological problem that would interfere with the conduction of the study protocol. Patients with symptoms of the midline at the state of off medication such as severe language barrier, dysphagia, disequilibrium, slipping-clutch gaitwere excluded. Patients who had undergone other implantation such as cardiac pacemaker, artificial cochlea because of the accompanied diseases such as were excluded. Patients with history of pallidotomy, stereotactic radiofrequency (Gamma Knife) and cell transplantation were also excluded.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scalemotor score;Activities of daily living (UPDRS-II scores) in the "Med off" state;Levodopa equivalent daily dose; | — |
Primary
| Measure | Time frame |
|---|---|
| Number of hours per day spent in the "on" state without dyskinesia;Unified Parkinson's Disease Rating Scalemotor score; | — |
Countries
China
Contacts
Public ContactJianguo Zhang
Outcome results
None listed