Status:
UNKNOWN
Spinal Cord Stimulation Therapy for Hereditary Spastic Paraplegias Patients
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Motor Function
Gait
Eligibility:
All Genders
14-70 years
Phase:
NA
Brief Summary
It's a single-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal cord stimulation (SCS) on motor function and ...
Detailed Description
Pure hereditary spastic paraplegia is a heterogeneous group of genetic disorders characterized by degeneration of the corticospinal tracts, coursing with progressive weakness and spasticity of the low...
Eligibility Criteria
Inclusion
- aged between 14 and 70 years
- patients with pure hereditary spastic paraplegias
- with progressive weakness and spasticity of the lower limbs, 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 :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05196178
Start Date
November 15 2021
End Date
December 1 2023
Last Update
January 19 2022
Active Locations (1)
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1
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100053