Spinal Cord Injury CervicalLEAPNCT07784088
Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
A study testing IWBCIS in people with Spinal Cord Injury Cervical and Tetraplegia/Tetraparesis, run by BCIFlex Medical Technology Co., Ltd. at 1 site in China.
Trial summary
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury Cervical, Tetraplegia/Tetraparesis, Spinal Cord Injuries (SCI)
- What is being tested?
- IWBCIS
- 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
- 15 Jul 2026to Jul 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
- Age ≥18 years and ≤65 years, male or female;
- Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B;
- Intact cognitive function, MoCA-BLIND score ≥19;
- Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI;
- Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions;
- Tetraplegia diagnosed for ≥12 months, stable clinical status ≥6 months after standard treatment;
- Good compliance, voluntary participation; informed consent signed by subject or legal representative.
Who cannot join
- Syringomyelia, severe neuralgia or spasticity limiting training participation;
- Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;
- High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;
- Subjects implanted with CNS electrical stimulation medical devices;
- Unstable medical conditions, severe mental/cognitive disorders confounding endpoint assessment;
- Severe, unstable, uncontrolled complex regional pain syndrome;
Show all 13Show fewer
- Autoimmune-induced spinal cord dysfunction/injury;
- History of stroke, multiple sclerosis, drug-resistant epilepsy, Alzheimer's Disease;
- Peripheral neuropathy;
- Pregnant/breastfeeding females, females planning pregnancy during trial;
- Require MRI examinations during device implantation period;
- Participated in other clinical trials within 1 month prior to enrollment;
- Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.
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
Beijing Tiantan Hospital, Capital Medical University
Beijing
Wang Jia, MD, +86 10 5997 6512, jwttyy@126.com
About this study
Official title: A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.
- Being tested
- IWBCIS
- Keywords
- BCI, Tetraplegia, Spinal Cord Injuries (SCI)
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IWBCISDevice
Implantable wireless brain-computer interface systems
| Study group | Role | What they receive |
|---|---|---|
| Implanted Brain-Computer Interface | Experimental | Device: Implantable wireless brain-computer interface systems Receives: Device: IWBCIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of brain-controlled tasks
Measured: 2, 3, 6 months post-implant
Secondary outcomes (10)
Digital Instrumental Activities of Daily Living (dIADL)
Measured: 2, 3, 6 months post-implant
Brain Control Fluency Index
The Brain Control Fluency Index is defined as the mean Information Transfer Rate measured by the Web-Grid Task performed by the patients with implantable wireless Brain-Computer Interface System.
Measured: 2, 3, 6 months post-implant
Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline, 2, 3, 6 months post-implant
Average Monthly Device Usage Duration
Measured: 6 months post-implant
WHO Quality of Life BREF
Measured: Baseline, 2, 3, 6 months post-implant
Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Measured: Baseline, 2, 3, 6 months post-implant
Psychosocial Impact of Assistive Devices Scale (PIADS)
Measured: 2, 3, 6 months post-implant
Subject Satisfaction with the Device
Trial subject report questionnaire to measure the trial subject's satisfaction of using trial device.
Measured: 2, 3, 6 months post-implant
Investigator Satisfaction with Device Operation
Investigator report questionnaire to measure the investigator's satisfaction with device operation.
Measured: 2, 3, 6 months post-implant
Device Reliability
Device Reliability is measure by the Electrode Impedance of the Device
Measured: up to 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start15 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 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 Injury CervicalStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BCIFlex Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784088
- Sponsor's protocol ID
- ZR202601
- Acronym
- LEAP
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
- ClinicalTrials.gov ID
- NCT07784088
- Acronym / sponsor ID
- LEAP / ZR202601
- Keywords
- BCI, Tetraplegia, Spinal Cord Injuries (SCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- BCIFlex Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Aug 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.
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted Brain-Computer Interface | Experimental | Device: IWBCISDevice: Implantable wireless brain-computer interface systems |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years and ≤65 years, male or female;
- Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B;
- Intact cognitive function, MoCA-BLIND score ≥19;
- Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI;
- Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions;
Key exclusion criteria (13 listed)
- Syringomyelia, severe neuralgia or spasticity limiting training participation;
- Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;
- High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;
- Subjects implanted with CNS electrical stimulation medical devices;
- Unstable medical conditions, severe mental/cognitive disorders confounding endpoint assessment;
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 |
|---|---|---|
| IWBCISImplantable wireless brain-computer interface systems | Device | Implanted Brain-Computer Interface |
Primary outcome
Success rate of brain-controlled tasks
Time frame: 2, 3, 6 months post-implant
10 secondary outcomes
Digital Instrumental Activities of Daily Living (dIADL)
Time frame: 2, 3, 6 months post-implant
Brain Control Fluency Index
Time frame: 2, 3, 6 months post-implant
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 2, 3, 6 months post-implant
Average Monthly Device Usage Duration
Time frame: 6 months post-implant
WHO Quality of Life BREF
Time frame: Baseline, 2, 3, 6 months post-implant
Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Time frame: Baseline, 2, 3, 6 months post-implant
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: 2, 3, 6 months post-implant
Subject Satisfaction with the Device
Time frame: 2, 3, 6 months post-implant
Investigator Satisfaction with Device Operation
Time frame: 2, 3, 6 months post-implant
Device Reliability
Time frame: up to 6 months post-implant
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 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury Cervical
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
RecruitingPhase 1
NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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 IWBCIS in people with Spinal Cord Injury Cervical and Tetraplegia/Tetraparesis, run by BCIFlex Medical 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 7 inclusion and 13 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 25 Aug 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 BCIFlex (+86 10 5365 7080, wangxp@bciflex.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: 2, 3, 6 months post-implant). 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 Aug 2026.