NCT04367116

The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is an open-label, prospective, single-arm, unicentral (Huashan Hospital Department of Neurology/ Neurosurgery) and exploratory clinical trial. Subjects will be enrolled from Parkinson's disease and Movement Disorder specialized outpatient department of Neurology in Huashan Hospital and network platform of chronic diseases. Spinal Cord Stimultion (SCS) will be performed in department of Neurosurgery and cerebral metabolism will be assessed in PET center of Huashan Hospital. Specialists in Neurology will follow up 3 months to record any unsafe incidents of progressive supranuclear palsy patients after the SCS surgery to evaluate safety. Meanwhile, improvement in gait disorder (including 10MWT and TUG test score) will be measured to evaluate efficacy.

Detailed description

The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy is an open-label, prospective, single-arm, unicentral and exploratory clinical trial. In the screening stage, patients clinically and radiologically diagnosed as progressive supranuclear palsy with prominent gait disturbance will be enrolled. Then comprehensive evaluations and spinal cord stimulation will be performed on patients eligible for stimulation. In the subsequent process of neuromodulation, changes of clinical presentations and cerebral metabolism of participants will be assessed. Any unsafe incidents in process will be recorded in detail.

Conditions

• Progressive Supranuclear Palsy
• Spinal Cord Stimulation

Interventions

Type	Name	Description
PROCEDURE	Spinal Cord Stimulation	Spinal cord stimulation is a treatment that implants a electrode in posterior epidural space of patient's spinal canal to send mild electric current to stimulate conducting bundle of the posterior column of the spinal cord and posterior horn sensory neurons.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-12-27
• Completion: 2023-12-27
• First posted: 2020-04-29
• Last updated: 2024-01-02

Locations

1 site across 1 country: China