Spinal Cord InjuryNCT07603752
Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study
A study testing WRS in people with Spinal Cord Injury, run by Shanghai StairMed Technology Co., Ltd. at 1 site in China.
Trial summary
This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- WRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years old (inclusive), with no restriction on gender.
- Meeting all the following requirements:
- Suffering from complete or incomplete tetraplegia secondary to cervical spinal cord injury (C2-C6); (2) Diagnosed in line with the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) issued by the American Spinal Injury Association (ASIA), with neurological injury grade classified as Grade A to Grade C; (3) Having fulfilled the above diagnostic criteria for no less than 12 months; 3. Confirmed by imaging examinations and neurological evaluations that the motor-related cerebral cortex is structurally intact, functionally normal and free of obvious atrophy, organic lesions or functional disorders; 4. Fertile participants must agree to use effective contraception throughout the trial period; 5. Participants, either independently or with caregiver assistance, are willing to follow investigators' guidance, comply with all procedures stipulated in the study protocol and complete all scheduled trial visits as required; 6. Having normal cognitive function with a Mini-Mental State Examination (MMSE) score ≥20 points (excluding three-step commands, writing and drawing items); 7. Elbow flexor muscle strength ≤ Grade 3 assessed by ISNCSCI scale; 8. Being of good compliance, voluntarily participating in the clinical trial and signing the informed consent form.
Who cannot join
- Having received implantation of any metallic objects or devices in the body (e.g., pacemaker, defibrillator, neurostimulator, cochlear implant, electronic devices, drug infusion pumps, etc.), excluding dental metallic implants or other implants confirmed to have no impact on the study.
- Long-term use of anticoagulants or antiplatelet drugs prior to screening, with antiplatelet drugs not discontinued for at least 2 weeks before surgery; or suffering from hematological diseases such as aplastic anemia and systemic lupus erythematosus; or having clinically significant abnormal coagulation function during the screening period.
- Having contraindications to magnetic resonance imaging (MRI) or being unable to complete MRI examinations for other reasons.
- Being assessed by anesthesiologists as intolerant to anesthetic surgery.
- Having neurological diseases (e.g., cerebrovascular lesions, intracranial infection, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma leading to severe brain dysfunction or obvious abnormal electroencephalographic signals, as judged by investigators.
- Suffering from physical or pathological conditions that may cause failed normal healing of scalp wounds.
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- Being in the stage of acute infection or suffering from other severe infections.
- Having any unstable or severe medical conditions that may interfere with study procedures or confound the evaluation of study endpoints, including previously diagnosed mania, depression, Alzheimer's disease, mood disorders, intellectual disability, other cognitive disorders, severe attention deficit, etc.
- Suffering from severe dysfunction of vital organs including heart, lung, liver and kidney: such as severe cardiovascular diseases (e.g., hospitalization or cardiac surgery due to myocardial infarction within 3 months, congestive heart failure, myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm); severe pulmonary diseases (moderate to severe pneumonia, respiratory failure, etc.).
- Diagnosed with malignant tumors, autoimmune diseases, peripheral neuropathy, poorly controlled diabetes mellitus, or other severe diseases deemed unsuitable for this clinical trial by investigators.
- Severe spasticity, severe neuralgia, or uncontrolled complex regional pain syndrome that hinders participants from completing training sessions.
- Spinal cord dysfunction or injury caused by autoimmune disorders.
- Having visual impairment that makes it difficult to view display screens for a long time even with standard corrective lenses.
- Suffering from infectious diseases such as active pulmonary tuberculosis, viral hepatitis (hepatitis B, hepatitis C), syphilis and AIDS.
- Receiving pharmacotherapy or physical therapy affecting the central nervous system before enrollment, and unable to discontinue such treatments after enrollment as assessed by investigators.
- Having a history of drug abuse, nicotine dependence or alcohol dependence.
- Pregnant or lactating females, or those planning to become pregnant during the study period.
- Having participated or currently participating in any drug clinical trial within 90 days prior to enrollment, or any other medical device clinical trial within 30 days prior to enrollment.
- Any other conditions deemed inappropriate for participation in this clinical trial by investigators.
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
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Ying Mao, Ph.D, +86 021 5288 8045, maoying@fudan.edu.cn
About this study
Official title: A Prospective, Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of an Implantable Wireless Brain-machine Interface System in Patients With Spinal Cord Injury
This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety.
- Conditions
- Spinal Cord Injury
- Being tested
- WRS
- 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.
WRSDevice
WRS is a minimally invasive, wireless brain-machine interface system
| Study group | Role | What they receive |
|---|---|---|
| Implantation of the WRS | Experimental | Not described Receives: Device: WRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of brain-controlled tasks
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control task
Measured: 3 months post-operation
Secondary outcomes (10)
success rate of brain-controlled tasks
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control
Measured: 6 months post-operation
Brain Control Fluency Index
Measured: up to 180 days
Task Accuracy
Measured: up to 180 days
Device Reliability
Measured: up to 180 days
Device Usage Duration
Measured: up to 180 days
Evaluation of Brain-Controlled Wheelchair
Measured: 3 and 6 months post-operation
WHOQOL-BREF
Measured: 3 and 6 months post-operation
dIADL
Measured: 3 and 6 months post-operation
HADS-A
Measured: 3 and 6 months post-operation
PHQ-9
Measured: 3 and 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start28 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603752
- Sponsor's protocol ID
- STAIRSUP-001
- Other IDs
- 2026-825
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of an Implantable Wireless Brain-machine Interface System in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07603752
- Acronym / sponsor ID
- STAIRSUP-001
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 May 2026 (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.
This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of the WRS | Experimental | Device: WRS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65 years old (inclusive), with no restriction on gender.
- Meeting all the following requirements:
- Suffering from complete or incomplete tetraplegia secondary to cervical spinal cord injury (C2-C6); (2) Diagnosed in line with the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) issued by the American Spinal Injury Association (ASIA), with neurological injury grade classified as Grade A to Grade C; (3) Having fulfilled the above diagnostic criteria for no less than 12 months; 3. Confirmed by imaging examinations and neurological evaluations that the motor-related cerebral cortex is structurally intact, functionally normal and free of obvious atrophy, organic lesions or functional disorders; 4. Fertile participants must agree to use effective contraception throughout the trial period; 5. Participants, either independently or with caregiver assistance, are willing to follow investigators' guidance, comply with all procedures stipulated in the study protocol and complete all scheduled trial visits as required; 6. Having normal cognitive function with a Mini-Mental State Examination (MMSE) score ≥20 points (excluding three-step commands, writing and drawing items); 7. Elbow flexor muscle strength ≤ Grade 3 assessed by ISNCSCI scale; 8. Being of good compliance, voluntarily participating in the clinical trial and signing the informed consent form.
Key exclusion criteria (19 listed)
- Having received implantation of any metallic objects or devices in the body (e.g., pacemaker, defibrillator, neurostimulator, cochlear implant, electronic devices, drug infusion pumps, etc.), excluding dental metallic implants or other implants confirmed to have no impact on the study.
- Long-term use of anticoagulants or antiplatelet drugs prior to screening, with antiplatelet drugs not discontinued for at least 2 weeks before surgery; or suffering from hematological diseases such as aplastic anemia and systemic lupus erythematosus; or having clinically significant abnormal coagulation function during the screening period.
- Having contraindications to magnetic resonance imaging (MRI) or being unable to complete MRI examinations for other reasons.
- Being assessed by anesthesiologists as intolerant to anesthetic surgery.
- Having neurological diseases (e.g., cerebrovascular lesions, intracranial infection, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma leading to severe brain dysfunction or obvious abnormal electroencephalographic signals, as judged by investigators.
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 |
|---|---|---|
| WRSWRS is a minimally invasive, wireless brain-machine interface system | Device | Implantation of the WRS |
Primary outcome
success rate of brain-controlled tasks
Time frame: 3 months post-operation
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control task
10 secondary outcomes
success rate of brain-controlled tasks
Time frame: 6 months post-operation
Brain Control Fluency Index
Time frame: up to 180 days
Task Accuracy
Time frame: up to 180 days
Device Reliability
Time frame: up to 180 days
Device Usage Duration
Time frame: up to 180 days
Evaluation of Brain-Controlled Wheelchair
Time frame: 3 and 6 months post-operation
WHOQOL-BREF
Time frame: 3 and 6 months post-operation
dIADL
Time frame: 3 and 6 months post-operation
HADS-A
Time frame: 3 and 6 months post-operation
PHQ-9
Time frame: 3 and 6 months post-operation
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 22 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WRS in people with Spinal Cord Injury, run by Shanghai StairMed Technology Co., Ltd. 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 3 inclusion and 19 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 22 May 2026. 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.
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 Clinical team Stairmed (+86 021-80510178, yumiao@stairmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of brain-controlled tasks (time frame: 3 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.