idiopathic Parkinson's disease
Conditions
Interventions
trial group:subthalamic nucleus stimulation
Sponsors
Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18 to 75 years old, Female or male; 2) Signed and dated informed consent document indicating the patient is willing to participate in the trial; 3) Diagnosed with idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria, and had the disease for 5 years or more; 4) Response to levodopa, but the therapeutic effect decline or motor fluctuation/dyskinesia emerge; 5) Have received optimal medication; 6) A disease severity rating between stage 2.5 and 4 in the off-medication condition, according to the Hoehn and Yahr scale; 7) Patients or caregivers could fill out the patient diary and return to hospital for follow-up study; 8) An improvement in the UPDRS motor score (part 3) of 33% or more when comparing off medication (overnight) to best on medication score was required at baseline;9) 4 h or more daily off time reported in the patient diary.
Exclusion criteria
Exclusion criteria: 1) Parkinsonism or Parkinsonism plus syndrome; 2) Severe cognitive impairment; 3) Mental illness,acute psychosis, epilepsy, and any medical or psychological problem that would interfere with the conduction of the study protocol; 4) Suffer from malignant tumor; 5) Brain injury history; 6) Take anticoagulant drugs or have the hemorrhagic tendency; 7) Pregnant woman or plan to pregnancy; 8) durg addiction or alcohol addiction; 9) Underwent electric shock therapy before; 10) Participate in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale, parts II; | — |
Secondary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale, parts II;daily on-time;daily off-time;levodopa equivalent dos; | — |
Contacts
Public ContactGao Guodong
Outcome results
None listed