Spinal Cord InjuriesPhase 1COFUNNCT04969042
Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
A Phase 1 study testing Pins Medical G122 RS in people with Spinal Cord Injuries, run by Luming Li at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Pins Medical G122 RS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Engineering Laboratory for Neuromodulation
Beijing, Beijing Municipality
Yang Lu, MD, yanglu@btch.edu.cn
About this study
Official title: Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
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
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Pins Medical G122 RS
- Keywords
- Spinal Cord Stimulation, Closed-Loop
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pins Medical G122 RSDevice
G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | Participants will receive pre-implantation rehabilitation, implantation of the closed-loop spinal cord stimulator, and stimulation (according to the functional mapping) assisted rehabilitation post-implantation during the trial. Receives: Device: Pins Medical G122 RS |
What is being measured
The primary outcome is the main question the study is designed to answer.
WISCI III
A Common method used to evaluate SCI patient's walking capability in clinical setting
Measured: Change from Baseline to the 8 month after implantation.
10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking
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.
Measured: Change from Baseline to the 8 month after implantation.
Weight Bearing Capacity
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
Measured: Change from Baseline to the 8 month after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luming Li
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Responsible party
- Sponsor-investigator, Luming Li, Tsinghua University
- Investigators
- Luming Li, PhD, Principal investigator, National Engineering Laboratory for Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969042
- Sponsor's protocol ID
- 202000325
- Acronym
- COFUN
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42209714
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04969042
- Acronym / sponsor ID
- COFUN / 202000325
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Stimulation, Closed-Loop
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Luming LiUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Pins Medical G122 RSParticipants will receive pre-implantation rehabilitation, implantation of the closed-loop spinal cord stimulator, and stimulation (according to the functional mapping) assisted rehabilitation post-implantation during the trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pins Medical G122 RSG122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space | Device | Stimulation |
Primary outcome
WISCI III
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 42209714Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luming Li, PhD principal investigator
National Engineering Laboratory for Neuromodulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pins Medical G122 RS in people with Spinal Cord Injuries, run by Luming Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Lu, MD (+8656119530, yanglu@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WISCI III (time frame: Change from Baseline to the 8 month after implantation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.