Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-01 @ 3:36 AM
Study NCT ID:
NCT04683861
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Stimulation Therapy for Freezing of Gait in Parkinson's Syndrome Patients
Sponsor:
zhangyuqing
Organization:
Study Overview
Official Title:
Spinal Cord Stimulation Therapy for Freezing of Gait in Patients With Advanced Parkinson's Disease and Parkinsonism-Plus Syndrome
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal cord stimulation may be a new therapeutic approach for freezing of gait. It's a multi-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease and Parkinsonism-Plus syndrome.
Detailed Description:
Benefits of dopaminergic therapy and deep brain stimulation are limited for freezing of gait in Parkinson's syndrome. Spinal cord stimulation is a well-established therapy for the treatment of chronic neuropathic pain. Recently, some pilot studies demonstrated the safety and significant therapeutic effect of Spinal cord stimulation in freezing of gait patients suffering from various movement disorders, such as Parkinson's disease, primary progressive freezing of gait, and multiple system atrophy with predominant Parkinsonism. Spinal cord stimulation may be a new therapeutic approach for freezing of gait. However, evidence from larger numbers of subjects is still lacking, especially little is known about its efficacy for gait and posture dysfunction in Parkinsonism-Plus syndrome patients. The objective of this study is to investigate the therapeutic effect and safety of spinal cord stimulation for freezing of gait in patients with advanced Parkinson's disease and Parkinsonism-Plus syndrome.
It's a multi-center, prospective, open label clinical study with a 12 months follow-up period. The intended study population is individuals suffering from advanced Parkinson's disease, multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy. Each participant will complete an enrollment/screening/baseline visit, a spinal cord stimulation implant and activation visit, and a minimum of two follow-up visits, including visit at 3 months and the final study visit at 12months. The participants will proceed to implantation after satisfying implant inclusion and exclusion criteria. Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, Minneapolis, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12. Electrode position will be verified by X-ray. The stimulators will be turned on within 1 month after electrode implantation surgery. The stimulation parameters could vary freely, but medications will be kept constant during the study period. At the end of month 12, participants will enter the long-term follow-up in which medications and stimulation parameters could vary freely.
It's a multi-center, prospective, open label clinical study with a 12 months follow-up period. The intended study population is individuals suffering from advanced Parkinson's disease, multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy. Each participant will complete an enrollment/screening/baseline visit, a spinal cord stimulation implant and activation visit, and a minimum of two follow-up visits, including visit at 3 months and the final study visit at 12months. The participants will proceed to implantation after satisfying implant inclusion and exclusion criteria. Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, Minneapolis, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12. Electrode position will be verified by X-ray. The stimulators will be turned on within 1 month after electrode implantation surgery. The stimulation parameters could vary freely, but medications will be kept constant during the study period. At the end of month 12, participants will enter the long-term follow-up in which medications and stimulation parameters could vary freely.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: