NCT06078397

Remote Programming for Deep Brain Stimulation in Parkinson's Disease.

Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP).

Detailed description

This is a randomized controlled trial aiming at comparing the efficacy of RP and SP in post-operative management of PD patients with DBS. Enrolled patients will be randomly assigned to the RP or SP groups before surgery. After recording baseline data, regular programming sessions will be conducted through RP or SP. Patients will be followed up in 6 months after implantation, with the main goal of the differences in motor symptom improvement between the two groups and the secondary goal of the difference in safety and economic benefits between both methods.

Conditions

• Deep Brain Stimulation
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	remote programming	Remote programming (RP) is a new type of patient management method after DBS surgery, which allows physicians to understand the patient's movement symptoms and adjust parameters through video conferencing. At the same time, the RP system also includes device checks, medication adjustments, psychological counseling, and other contents. Compared to standard programming that requires going to the hospital, the application of RP can save the burden on patients and their caregivers.
DEVICE	standard programming	Programming refers to a series of methods that set the parameters of the IPG after the implantation of DBS, and adjust the device parameters based on the patient's symptoms during subsequent follow-up to maintain the efficacy of electrical stimulation.

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-01-30
• Completion: 2025-06-30
• First posted: 2023-10-11
• Last updated: 2024-02-22

Locations

1 site across 1 country: China