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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Huashan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jian-Jun Wu, MD
jungliw@gmail.com
86-21-52888163
Backup
Feng-Tao Liu, MD
liufengtao@fudan.edu.cn
86-21-52888163
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 50
Treatments
Active_comparator: empirical stimulation modes group (ESG)
empirical programming for the first 9 months' period, followed by any stimulation decided by the neurologists/neurosurgeons for the final 3 months.
Experimental: interleaving stimulation modes group (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.
Sponsors
Leads: Huashan Hospital
Collaborators: Medtronic

This content was sourced from clinicaltrials.gov