Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pins Medical G122 RS.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
Overview
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
- Device Pins Medical G122 RS
G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space
Primary outcome measures
- WISCI III [Time frame: Change from Baseline to the 8 month after implantation.]
- 10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking [Time frame: Change from Baseline to the 8 month after implantation.]
- Weight Bearing Capacity [Time frame: Change from Baseline to the 8 month after implantation.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Engineering Laboratory for Neuromodulation — Beijing
Publications
- Li H, Wei Y, Sui Y, Zhang X, Luo X, Zhang B, Ma B. Predict neuromuscular performance in human epidural electrical stimulation: phase 1 trial interim results. Commun Med (Lond). 2026 May 29. doi: 10.1038/s43856-026-01695-3. Online ahead of print. PMID 42209714
Identifiers
NCT: NCT04969042 · 202000325