Complete or Incomplete Paraplegia/quadriplegiaRISENCT06829212
Research on Wireless Brain Implant System for General Control of External Devices
A study testing WRS in people with Complete or Incomplete Paraplegia/quadriplegia and Spinal Cord Injury, run by Shanghai StairMed Technology Co., Ltd. at 1 site in China.
Trial summary
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke
- What is being tested?
- WRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Mar 2025to Feb 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years (inclusive), any gender.
- Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
- Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
- Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
- Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
Who cannot join
- Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
- Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
- Unable to tolerate anesthesia or surgery.
- Severe neurological disorders or brain injury leading to significant dysfunction.
- Scalp conditions that may impair wound healing.
- Acute or severe infections.
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- Cognitive impairment or psychiatric disorders.
- Severe dysfunction of vital organs, malignancies, or autoimmune diseases.
- Life expectancy under 1 year.
- Drug or alcohol abuse.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Other conditions deemed unsuitable by the investigator.
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 Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Junfeng Lu, Dr., 021-54601999, sherley_76@163.com
About this study
Official title: A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed/Amputee Patients
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.
WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.
Read the detailed description
The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience.
The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis, Bilateral Upper Limb Amputation
- Being tested
- WRS
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries, Brain Stem Infarctions, Amyotrophic Lateral Sclerosis
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, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).
| Study group | Role | What they receive |
|---|---|---|
| Implantation | Experimental | Implantation of the WRS64 Receives: Device: WRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-Related Adverse Events (AE)
Measured: Through study completion, an average of 7 months
Secondary outcomes (7)
Adverse Events
Measured: Through study completion, an average of 7 months
Serious Adverse Event
Measured: Through study completion, an average of 7 months
BPS
Bits per second, determined by the net number of correct targets selected per minute (NTPM) during task participation by the subject, and the grid size.
Measured: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Usage Time (hours/month)
The amount of time the subject uses the experimental device each month.
Measured: At an average of 5 to 7 months after implantation, during the follow-up phases.
Accuracy
The percentage of correctly completed commands from the total commands in the predefined task list, which are independently completed by the subject within a specified time.
Measured: At an average of 5 to 7 months after implantation, during the follow-up phases.
Psychological State
The subject and/or their caregiver will complete the checklist to assess psychological states and other relevant indicators (each question is graded from 1 to 5, with lower values being better).
Measured: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Caregiver Burden
The subject's caregiver will complete the checklist to assess caregiver burden and other related indicators (each question is scored from 0 to 4, with lower scores being better).
Measured: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete or Incomplete Paraplegia/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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT06829212
- Sponsor's protocol ID
- PI2302-CL-01-001
- Other IDs
- 2024-1325
- Acronym
- RISE
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2025
- Last updated
- 13 Mar 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed/Amputee Patients
- ClinicalTrials.gov ID
- NCT06829212
- Acronym / sponsor ID
- RISE / PI2302-CL-01-001
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis, Bilateral Upper Limb Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- Mar 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Feb 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 clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.
WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.
Detailed description
The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience.
The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation | Experimental | Device: WRSImplantation of the WRS64 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-80 years (inclusive), any gender.
- Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
- Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
- Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
- Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
Key exclusion criteria (12 listed)
- Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
- Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
- Unable to tolerate anesthesia or surgery.
- Severe neurological disorders or brain injury leading to significant dysfunction.
- Scalp conditions that may impair wound healing.
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, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01). | Device | Implantation |
Primary outcome
Device-Related Adverse Events (AE)
Time frame: Through study completion, an average of 7 months
7 secondary outcomes
Adverse Events
Time frame: Through study completion, an average of 7 months
Serious Adverse Event
Time frame: Through study completion, an average of 7 months
BPS
Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Usage Time (hours/month)
Time frame: At an average of 5 to 7 months after implantation, during the follow-up phases.
Accuracy
Time frame: At an average of 5 to 7 months after implantation, during the follow-up phases.
Psychological State
Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Caregiver Burden
Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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 Complete or Incomplete Paraplegia/quadriplegia and 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 5 inclusion and 12 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 13 Mar 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 (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?
Device-Related Adverse Events (AE) (time frame: Through study completion, an average of 7 months). 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 13 Mar 2025.