Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Stimulation, Closed-Loop
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
Detailed description
The whole course will last around 12 months, during which there will be: Pre-implant evaluations and standard rehabilitation (6-10 weeks), Stimulator implantation and stimulation optimization (4-8 weeks), Rehabilitation training with stimulation (6 months). At the end of the protocol, the study aims to make the patients walk better and faster.
Interventions
DEVICEPins Medical G122 RS
G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space
Sponsors
Beijing Tsinghua Changgeng Hospital
Luming Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WISCI III | Change from Baseline to the 8 month after implantation. | A Common method used to evaluate SCI patient's walking capability in clinical setting |
| 10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking | Change from Baseline to the 8 month after implantation. | 10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: a self-selected normal speed, and a self-selected 'faster-than-normal' speed. |
| Weight Bearing Capacity | Change from Baseline to the 8 month after implantation. | Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently. The investigators use LPG HUBER360 to examine subjects' weight bearing capacity |
Countries
China
Contacts
Primary ContactYang Lu, MD
Outcome results
None listed