Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease: Randomized, Double-blind, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Huashan Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Parkinson's disease quality of life-39 (PDQ-39) scores
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is designed as a prospective, randomized, double-blind, controlled study to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to post-operation dyskinesia control. The primary objective is to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to dyskinesia control.
Detailed Description
This study is designed as a prospective, randomized, double-blind, controlled study to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to post-operation dyskinesia control. The primary objective is to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to dyskinesia control. 50 Patients will be randomly assigned to either the interleaving stimulation modes group (ISG) or the empirical stimulation modes group (ESG). In ISG, empirical stimulation for the first 3 months, followed by interleaving programming period for 6 months, and any stimulation decided by the neurologists/neurosurgeons for the final 3 months. In ESG, empirical programming for the first 9 months' period, followed by any stimulation decided by the neurologists/neurosurgeons for the final 3 months. The change of dyskinesia scores (UPDRS IV, item 32 + item 33), Parkinson's disease quality of life-39 (PDQ-39) scores, scores of United Parkinson's Disease Rating Scale Part III as well as scores of neuropsychological Battery in interleaving stimulation compared to empirical programming modes will be measured based on corresponding time frame. Finally, the results will be analyzed via proper statistical methods and thus the conclusion will be drawn.
Investigators
Jian Wang
Professor of neuroloy department
Huashan Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients at the age of 30-65 years old.
- •Patients diagnosed as Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria.
- •Patients at Hoehn and Yahr stage 3 or lower in the on-state and stage 2 - 4 in the off-state.
- •The disease duration of 5 years or more.
- •Patients with deep levodopa-responsive Parkinson's disease, and are not adequately controlled by drug therapy.
Exclusion Criteria
- •major illness or medical comorbidities, depression that is untreated but judged to be clinically significant by an investigator, cochlear implants, cardiac pacemakers, needs for diathermy, anticoagulant therapy, previous neuro-surgical procedure or ablative therapy, frank dementia according to cognitive screening, drug or alcohol abuse, being a woman of child-bearing potential, having a positive pregnancy test, or presence of a terminal illness.
Outcomes
Primary Outcomes
Parkinson's disease quality of life-39 (PDQ-39) scores
Time Frame: 3 months and 9 months
Measure the changes of Parkinson's disease quality of life-39 (PDQ-39) scores in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (good health) to 156 (poor health).
dyskinesia scores (United Parkinson's Disease Rating Scale Part IV, item 32 + item 33)
Time Frame: 3 months and 9 months
Measure the changes of dyskinesia scores (United Parkinson's Disease Rating Scale Part IV, item 32 + item 33) in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (good health) to 4 (poor health).
Secondary Outcomes
- scores of United Parkinson's Disease Rating Scale Part III(3 months and 9 months)
- Montreal cognitive assessment scores(3 months and 9 months)