QuadriplegiaSTAIRNCT06944834
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
A study testing Implant in people with Quadriplegia and Amputations, run by Shanghai StairMed Technology Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quadriplegia, Amputations, Spinal Cord Injuries (SCI)
- What is being tested?
- Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Apr 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
- Adults aged 18-65 years;
- Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
- Normal motor cortex function confirmed by neurological assessment;
- Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
- Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;
- Expected lifespan ≥12 months;
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- Normal cognitive function;
- Normal hearing and vision, or corrected vision to normal with standard lenses;
- Patients with stable caregivers;
- Willing to sign informed consent and able to comply with follow-up requirements.
Who cannot join
- Patients with neuropsychiatric disorders or psychological impairments;
- Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
- History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
- History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
- Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;
- Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists;
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- Morbid obesity (BMI >40);
- Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;
- Current participation in other clinical trials;
- Other conditions considered unsuitable by investigators or medical staff.
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
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038
Ruili Zhang, Ph.D, +86 29 8471 7761, zhang.ruili@qq.com
About this study
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
Read the detailed description
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
- Being tested
- Implant
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries, Brain Stem Infarctions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantDevice
Implantation of the device and follow-up
| Study group | Role | What they receive |
|---|---|---|
| Implantation of the WRS64 | Experimental | Implantation of the device and follow-up Receives: Device: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The incidence of adverse events associated with the device or surgical procedure
Measured: Within 6 months after implantation
Secondary outcomes (9)
WRS Efficacy Assessment- Accuracy
Validation of motor function improvement through cursor control performance metrics: the accuracy of of task list (number of correct items/ number of all items), the higher the better.
Measured: 6 months after the implantation
WRS Efficacy Assessment- Path efficiency
Validation of motor function improvement is demonstrated through cursor control performance metrics, particularly path efficiency (the ratio of optimal to actual movement path). Higher values indicate better motor control performance.
Measured: 6 months after the implantation
WRS Efficacy Assessment- Time consumption
Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance.
Measured: 6 months after the implantation
Neurological Recovery Assessment
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale was used to evaluate overall neurological status. The higher the scale score, the better the overall neurological status.
Measured: 3, 15, 30, 90, 180 days after implantation
Changes in Quality of Life
Variations in the MOS item short from health survey (SF-36) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). The score values directly reflect health status - higher scores indicate better functional outcomes and superior quality of life.
Measured: 3, 15, 30, 90, 180 days after implantation
Changes in Cognitive Performance
Variations in Montreal Cognitive Assessment (MoCA) scores scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Elevated scores are associated with improved cognitive function.
Measured: 3, 15, 30, 90, 180 days after implantation
Changes in Psychological Status
Variations in Patient Health Questionnaire (PHQ-9) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
Measured: 3, 15, 30, 90, 180 days after implantation
Changes in Anxiety Status
Variations in Hamilton Anxiety Rating Scale (HAMA) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
Measured: 3, 15, 30, 90, 180 days after implantation
Changes in Depression Status
Variations in Hamilton Depression Rating Scale (HAMD) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
Measured: 3, 15, 30, 90, 180 days after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuadriplegiaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944834
- Sponsor's protocol ID
- PI2302-CL-01-002
- Other IDs
- JJ202503-01
- Acronym
- STAIR
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2025
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
- ClinicalTrials.gov ID
- NCT06944834
- Acronym / sponsor ID
- STAIR / PI2302-CL-01-002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Apr 2025 (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 objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
Detailed description
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of the WRS64 | Experimental | Device: ImplantImplantation of the device and follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged 18-65 years;
- Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
- Normal motor cortex function confirmed by neurological assessment;
- Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
- Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;
Key exclusion criteria (10 listed)
- Patients with neuropsychiatric disorders or psychological impairments;
- Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
- History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
- History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
- Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;
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 |
|---|---|---|
| ImplantImplantation of the device and follow-up | Device | Implantation of the WRS64 |
Primary outcome
Adverse events
Time frame: Within 6 months after implantation
The incidence of adverse events associated with the device or surgical procedure
9 secondary outcomes
WRS Efficacy Assessment- Accuracy
Time frame: 6 months after the implantation
WRS Efficacy Assessment- Path efficiency
Time frame: 6 months after the implantation
WRS Efficacy Assessment- Time consumption
Time frame: 6 months after the implantation
Neurological Recovery Assessment
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Quality of Life
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Cognitive Performance
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Psychological Status
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Anxiety Status
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Depression Status
Time frame: 3, 15, 30, 90, 180 days after implantation
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 25 Apr 2025.
- 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 Implant in people with Quadriplegia and Amputations, 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 25 Apr 2025. 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 Stairmed Clinical team (+86 021-80510178, kongcen@stairmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Within 6 months after implantation). 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 25 Apr 2025.