RecruitingPhase 1NCT04969042
Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
Sponsor
Luming Li
Enrollment
10 participants
Start Date
Aug 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this experiment is to evaluate the efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients after Spinal Cord Injury
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria7
- Age 18~70
- Spinal cord injury staging(AIS) A,B,C or D
- Level of lesion is T10 and above
- Distance between lesion and conus >60mm
- Injured Time > 3 months
- Capable of participating rehabilitation program
- Agree to comply with all conditions of the study and to attend all required study training and visits
Exclusion Criteria9
- With Obvious psychiatric disorder that cannot complete relevant questionaires
- Cognitive impairment
- Severe autonomic reflex disorder
- Severe muscle atrophy and joint contracture
- Cannot participate in spinal cord stimulation surgery or follow-up visits
- Life expectancy less than 12 months
- Abnormal blood or other physiological examinations that cannot conduct surgery, such as blood coagulation disorder or kidney/liver abnormalities
- Uncontrollable hypertension, heart diseases, respiratory diseases or took related medicine in last 3 months
- Unsuitable candidates in PI's perspective
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Interventions
DEVICEPins Medical G122 RS
G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04969042
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