Clinical trial NCT06239454: Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease
Official title: Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease: Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Interleaving stimulation
dyskinesia syndrome in in Parkinson's disease
randomized, double-blind, controlled trial
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2024-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: dyskinesia scores (United Parkinson's Disease Rating Scale Part IV, item 32 + item 33)
timeFrame: 3 months and 9 months
measure: Parkinson's disease quality of life-39 (PDQ-39) scores
timeFrame: 3 months and 9 months
Secondary outcomes:
measure: scores of United Parkinson's Disease Rating Scale Part III
timeFrame: 3 months and 9 months
measure: Montreal cognitive assessment scores
timeFrame: 3 months and 9 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Feng-Tao Liu, MD
role: STUDY_DIRECTOR
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