NCT04969042 Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
| NCT ID | NCT04969042 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Luming Li |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-08-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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