Parkinson's Disease
Conditions
Keywords
Interleaving stimulation, dyskinesia syndrome in in Parkinson's disease, randomized, double-blind, controlled trial
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.
Interventions
DEVICEinterleaving stimulation
ILS consists of two rapid and alternate stimulation programs with different contacts, amplitudes, and pulse width but the same frequency up to a maximum of 125Hz. Contact selection is determined by postoperative stereotactic computed tomography and clinical evaluation to achieve a balance between motor improvement and tolerable side effects. For example, ILS is successfully applied for PD motor symptoms (stimulation of subthalamic nucleus) as well as dyskinesia (additional stimulation of zona incerta).
DEVICEempirical stimulation
Patients are settled with simple polar stimulation with combined parameters adjustment (monopolar mode, 60\ 90µs pulse width, 130\ 185Hz frequency and varied voltage) during the follow-up.
Sponsors
Medtronic
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Randomization is done by computer-generated pairwise according to order of enrolment, so that similar numbers of patients are recruited to each study group. The chief investigator generates the randomization sequence. The randomization scheme is kept in sealed envelopes. The randomization sequence was revealed only to the unmasked clinician responsible for the stimulation programming, but not to the rater. Patients were masked to randomisation group.
Intervention model description
50 Patients will be randomly assigned to either the interleaving stimulation modes group (ISG) or the empirical stimulation modes group (ESG). 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. ESG: empirical programming for the first 9 months' period, followed by any stimulation decided by the neurologists/neurosurgeons for the final 3 months.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients at the age of 30-65 years old. 2. Patients diagnosed as Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria. 3\. Patients at Hoehn and Yahr stage 3 or lower in the on-state and stage 2 - 4 in the off-state. 4\. The disease duration of 5 years or more. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dyskinesia scores (United Parkinson's Disease Rating Scale Part IV, item 32 + item 33) | 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). |
| Parkinson's disease quality of life-39 (PDQ-39) scores | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| scores of United Parkinson's Disease Rating Scale Part III | 3 months and 9 months | Measure the changes of scores of United Parkinson's Disease Rating Scale Part III in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (good health) to 132 (poor health). |
| Montreal cognitive assessment scores | 3 months and 9 months | Measure the scores of Montreal cognitive assessment in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (poor cognition) to 30 (good cognition). |
Countries
China
Contacts
Primary ContactJian-Jun Wu, MD
Backup ContactFeng-Tao Liu, MD
Outcome results
None listed