NCT06239454

Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease

Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease: Randomized, Double-blind, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	interleaving 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).
DEVICE	empirical 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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-01
• Completion: 2025-02-28
• First posted: 2024-02-02
• Last updated: 2024-02-02

Locations

1 site across 1 country: China