Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord InjuryHC-IBCI-SE-TMFNCT07457645
Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia Patients
A study testing Invasive BCI in people with Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury
- What is being tested?
- Invasive BCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 15 Oct 2028
- 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
- 18-65 years old (no gender restriction)
- Clinically diagnosed with tetraplegic motor dysfunction following brainstem or spinal cord injury
- ≥ 6 months after brainstem or spinal cord injury, with stable condition (spinal shock phase has passed, and no significant improvement or deterioration in sensory and motor function)
- Bilateral upper limb muscle strength ≤ Grade 2 and bilateral lower limb muscle strength ≤ Grade 3 by Manual Muscle Testing (MMT)
- Cognitive function: Mini-Mental State Examination (MMSE) score ≥ 20
Who cannot join
- Females who are pregnant
- History of drug abuse or alcoholism
- Diseases that limit limb mobility: fractures (progressive/deformity-causing fractures), hip dysplasia and other diseases causing limited hip mobility, diabetic foot, severe osteoporosis, limb joint contracture deformity, spasticity, and hospitalization due to autonomic dysreflexia in the past 3 months
- Neurological diseases/injuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathies, severe anxiety or depression, and suicidal ideation
- Surgical contraindications: infectious diseases; unstable angina pectoris, severe arrhythmia, and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis; malignant tumors; spinal instability and spinal stenosis
- BMI ≥ 30.0 kg/m²
- Patients with depressive disorder (17-item Hamilton Depression Rating Scale [HAMD] score > 17)
- Patients unable to comply with the study protocol
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
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Hao Wang, PhD, +8602164041990, wang.hao@zs-hospital.sh.cn
About this study
Official title: Safety and Efficacy of High-Channel Implanted Brain-Computer Interface in Promoting Motor Function Improvement in Patients With Tetraplegia
This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.
- Being tested
- Invasive BCI
- 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.
Invasive BCIOther
Main Study Phase: Subjects undergo intracranial electrode implantation surgery. After surgery, motor intention decoding is performed on the electroencephalographic (EEG) signals recorded by the intracranial electrodes, and the decoded signals drive an external hand continuous passive motion device to achieve upper limb grasping movements.
Extension Phase: Subjects receive implantation of epidural spinal cord test electrodes, and undergo rehabilitation training with closed-loop epidural electrical stimulation based on signals from the implanted electrodes.
Follow-up Phase: It mainly involves functional training with closed-loop epidural electrical stimulation based on scalp EEG signals, as well as follow-up observation.
| Study group | Role | What they receive |
|---|---|---|
| IBCI | Experimental | Receive invasive BCI intervention Receives: Other: Invasive BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasping Success Rate
The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Secondary outcomes (17)
Grasping Object Type Coverage
The types of objects that can be accurately grasped (e.g., water cups, mobile phones, paper)
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Brain-Controlled Command Recognition Accuracy
The correctness of converting electroencephalographic (EEG) signals into grasping commands
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Grasping Latency
The time interval from when the brain generates a grasping intention to the execution of the grasping action
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Manual Muscle Testing (MMT)
Change from baseline in muscle strength assessed using the Medical Research Council (MRC) Manual Muscle Testing scale (grade 0-5; higher grade indicates greater muscle strength/better outcome).
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Modified Ashworth Scale (MAS) for Spasticity
Change from baseline in spasticity assessed using the Modified Ashworth Scale (MAS; 0-4 with a 1+ category; higher score indicates more severe spasticity/worse outcome).
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
3-Meter Walking Time
Change from baseline in time to complete a 3-meter walk, measured in seconds (s); lower time indicates better walking performance/better outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Width (Motion Capture)
Change from baseline in step width measured by motion capture gait analysis, reported in centimeters (cm).
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Length (Motion Capture)
Change from baseline in step length measured by motion capture gait analysis, reported in centimeters (cm); greater step length generally indicates better gait performance.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Height (Motion Capture)
Change from baseline in step height measured by motion capture gait analysis, reported in centimeters (cm).
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Frequency (Motion Capture)
Change from baseline in step frequency measured by motion capture gait analysis, reported in steps per minute (steps/min); higher frequency generally indicates better gait performance.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Walking Speed (Motion Capture)
Change from baseline in walking speed measured by motion capture gait analysis, reported in centimeters per second (cm/s); higher speed indicates better gait performance/better outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Plantar Pressure Value
Change from baseline in plantar peak pressure assessed using a plantar pressure measurement system, reported in kilopascals (kPa).
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Limb Muscle Volume
Change from baseline in limb muscle volume assessed using imaging-based volumetry, reported in cubic centimeters (cm³); higher volume indicates greater muscle mass/better outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Visual Analog Scale (VAS)
Change from baseline in pain intensity assessed using the Visual Analog Scale (VAS; 0-10, where 0 = no pain and 10 = worst pain imaginable); higher score indicates worse pain/worse outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Sexual Health Inventory for Men (SHIM) / Sexual Complaints Screener for Women (SCS-W)
Change from baseline in male sexual function assessed using the Sexual Health Inventory for Men (SHIM; total score 1-25); higher score indicates better erectile function/better outcome. OR Change from baseline in female sexual complaints assessed using the Sexual Complaints Screener for Women (SCS-W; total score 0-60); higher score indicates greater symptom severity/worse outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF) Score for Urinary Retention
Change from baseline in urinary symptoms assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; total score 0-21); higher score indicates more severe urinary symptoms/worse outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Neurogenic Bowel Dysfunction (NBD)
Change from baseline in bowel function assessed using the Neurogenic Bowel Dysfunction (NBD) score (total score 0-47); higher score indicates more severe bowel dysfunction/worse outcome.
Measured: Before surgery and 1 week, 1 month, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Ding, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457645
- Sponsor's protocol ID
- B2025-473
- Acronym
- HC-IBCI-SE-TMF
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD (Individual Participant Data) contains individual information of participants (such as demographic characteristics, medical history, examination results, and intervention responses). Even after the "de-identification process", there remains a risk that the participants' identities could be inferred through cross-validation (e.g., by combining regional, age, and disease characteristics). Compliance with global privacy protection regulations-such as China's Personal Information Protection Law-is required, as these regulations clearly stipulate that "individual sensitive medical data shall not be disclosed unless necessary" to prevent infringement of rights and interests (such as discrimination and identity abuse) caused by privacy leaks.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of High-Channel Implanted Brain-Computer Interface in Promoting Motor Function Improvement in Patients With Tetraplegia
- ClinicalTrials.gov ID
- NCT07457645
- Acronym / sponsor ID
- HC-IBCI-SE-TMF / B2025-473
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 9 Mar 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 an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBCI | Experimental | Other: Invasive BCIReceive invasive BCI intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old (no gender restriction)
- Clinically diagnosed with tetraplegic motor dysfunction following brainstem or spinal cord injury
- ≥ 6 months after brainstem or spinal cord injury, with stable condition (spinal shock phase has passed, and no significant improvement or deterioration in sensory and motor function)
- Bilateral upper limb muscle strength ≤ Grade 2 and bilateral lower limb muscle strength ≤ Grade 3 by Manual Muscle Testing (MMT)
- Cognitive function: Mini-Mental State Examination (MMSE) score ≥ 20
Key exclusion criteria (8 listed)
- Females who are pregnant
- History of drug abuse or alcoholism
- Diseases that limit limb mobility: fractures (progressive/deformity-causing fractures), hip dysplasia and other diseases causing limited hip mobility, diabetic foot, severe osteoporosis, limb joint contracture deformity, spasticity, and hospitalization due to autonomic dysreflexia in the past 3 months
- Neurological diseases/injuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathies, severe anxiety or depression, and suicidal ideation
- Surgical contraindications: infectious diseases; unstable angina pectoris, severe arrhythmia, and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis; malignant tumors; spinal instability and spinal stenosis
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 |
|---|---|---|
| Invasive BCIMain Study Phase: Subjects undergo intracranial electrode implantation surgery. After surgery, motor intention decoding is performed on the electroencephalographic (EEG) signals recorded by the intracranial electrodes, and the decoded signals drive an external hand continuous passive motion device to achieve upper limb grasping movements. Extension Phase: Subjects receive implantation of epidural spinal cord test electrodes, and undergo rehabilitation training with closed-loop epidural electrical stimulation based on signals from the implanted electrodes. Follow-up Phase: It mainly involves functional training with closed-loop epidural electrical stimulation based on scalp EEG signals, as well as follow-up observation. | Other | IBCI |
Primary outcome
Grasping Success Rate
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping
17 secondary outcomes
Grasping Object Type Coverage
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Brain-Controlled Command Recognition Accuracy
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Grasping Latency
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Manual Muscle Testing (MMT)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Modified Ashworth Scale (MAS) for Spasticity
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
3-Meter Walking Time
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Width (Motion Capture)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Length (Motion Capture)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Height (Motion Capture)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Step Frequency (Motion Capture)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Walking Speed (Motion Capture)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Plantar Pressure Value
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Limb Muscle Volume
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Visual Analog Scale (VAS)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Sexual Health Inventory for Men (SHIM) / Sexual Complaints Screener for Women (SCS-W)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF) Score for Urinary Retention
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Neurogenic Bowel Dysfunction (NBD)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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 28 Apr 2026.
- Individual participant dataSharing planned: No. IPD (Individual Participant Data) contains individual information of participants (such as demographic characteristics, medical history, examination results, and intervention responses). Even after the "de-identification process", there remains a risk that the participants' identities could be inferred through cross-validation (e.g., by combining regional, age, and disease characteristics). Compliance with global privacy protection regulations-such as China's Personal Information Protection Law-is required, as these regulations clearly stipulate that "individual sensitive medical data shall not be disclosed unless necessary" to prevent infringement of rights and interests (such as discrimination and identity abuse) caused by privacy leaks.
Related trials for Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
Jing Ding, PhD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive BCI in people with Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury, run by Shanghai Zhongshan Hospital 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 8 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 28 Apr 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 Jing Chen, PhD (+862164041990, chen.jing7@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grasping Success Rate (time frame: Before surgery and 1 week, 1 month, and 3 months after surgery). 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 28 Apr 2026.