Status:
UNKNOWN
Spinal Cord Stimulation Therapy for Freezing of Gait in Parkinson's Syndrome Patients
Lead Sponsor:
zhangyuqing
Conditions:
Freezing of Gait
Eligibility:
All Genders
40-76 years
Phase:
NA
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 therap...
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...
Eligibility Criteria
Inclusion
- aged between 40 and 76 years
- patients with advanced Parkinson's disease, or multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy (PSP)
- with significant freezing of gait ( Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale III item 11≥2), and the gait dysfunction treatable by medication but not adequately controlled with medications.
- Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.
Exclusion
- cognitive impairment ( MMSE≤24), depression (HAMD\>24),acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigatior's medical judgment
- surgical or medical contraindications to spinal cord stimulation surgery(e.g. uncontrolled hypertension, advanced coronary artery disease).
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04683861
Start Date
December 8 2020
End Date
December 1 2023
Last Update
December 24 2020
Active Locations (1)
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1
Capital Medical University of Xuanwu Hospital
Beijing, China