Spinal Cord Injury"Triple-F" BCINCT07720882
A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety
A study testing "Triple-F" BCI in people with Spinal Cord Injury, run by NeuroXess Technology (shanghai) Co.,Ltd. at 1 site in China.
Trial summary
This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this… 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?
- "Triple-F" BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2026to 30 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
- 18 years ≤ age ≤ 65 years, male or female;
- Cervical spinal cord injury (injury level C2-C6), with ASIA Impairment Scale grade A, B, or C;
- Severe impairment of hand function on the target upper extremity: finger flexor muscle strength < grade 3 as assessed by the ISNCSCI scale;
- ARAT score ≥ 2 for "hand to mouth"; score ≥ 1 for both "hand to top of head" and "hand to back of head"; and scores ≤ 1 for each of the grasp, grip, and pinch tasks;
- Neurological assessment confirms normal motor-related cortical function of the brain, with no acute cerebral functional changes;
- At least 12 months have elapsed since the cervical spinal cord injury resulting in tetraplegia, and the condition has been stable for at least 6 months following standardized treatment (with documentation of rehabilitation therapy records available);
Show all 9Show fewer
- Good cognitive function: Mini-Mental State Examination (MMSE) score ≥ 22 and Montreal Cognitive Assessment (MoCA) score ≥ 26 ;
- Possess the basic visual, auditory, and language comprehension abilities required for interaction, and be able to cooperate with training;
- The subject voluntarily participates and is willing to comply with the relevant examinations and follow-up visits.
Who cannot join
- Neurodegenerative diseases / secondary injury due to tumors, or severe autonomic dysreflexia;
- Presence of intracranial lesions or contraindications to intracranial implantation: active epilepsy or definite epileptogenic tendency; severe cerebrovascular disease; brain tumor; moderate-to-severe sequelae of traumatic brain injury; space-occupying lesions or structural abnormalities at the electrode implantation target area; already implanted with active implantable electronic devices such as cardiac pacemakers/defibrillators, cochlear implants, deep brain stimulators, or drug infusion pumps, or presence of local metal foreign bodies/implants in the area to be implanted; or other contraindications to intracranial implantation as assessed by the investigator;
- Malignancies in other organ systems;
- Cardiovascular system diseases: severe cardiac insufficiency, severe arrhythmias, or uncontrolled hypertension;
- Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy, nasogastric tube feeding, etc.);
- Presence of psychiatric or psychological disorders that may interfere with the subject's participation in BCI training, such as depression (HAMD ≥ 18 points) or anxiety disorder (HAMA ≥ 14 points) ;
Show all 15Show fewer
- Presence of active infection; severe coagulation abnormalities (activated partial thromboplastin time (APTT) or prothrombin time (PT) > 2.5 × upper limit of normal); or other severe systemic diseases that, as assessed by the investigator, may significantly increase surgical risk or interfere with neurological function assessment or system use;
- Contraindications to surgery or anesthesia, or deemed unsuitable for implantation surgery by anesthesiology/surgical assessment;
- Fever, or vital signs and/or intracranial status not yet stabilized;
- Upper-limb motor dysfunction due to other etiologies, such as amyotrophic lateral sclerosis, syringomyelia, spinal vascular diseases, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, peripheral nerve injury, tendon rupture, etc.;
- Planned MRI examination during the device implantation period;
- Life expectancy < 6 months (e.g., severe end-stage diseases);
- Participation in other drug or medical device clinical trials within the past 1 month;
- Pregnant or breastfeeding women;
- Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liang Chen, MD contact
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Prospective, Multicenter, Single-Arm Target Value Clinical Trial to Evaluate the Efficacy and Safety of Implantable Brain-Computer Interface Hand Motor Function Compensation System for Upper-Limb Functional Replacement in Tetraplegic Patients With Spinal Cord Injury
This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.
Read the detailed description
This trial adopts a prospective, multicenter, single-arm target value study design.
All enrolled subjects will receive implantation of an implantable brain-computer interface system for compensatory hand motor function, followed by standardized brain-computer training (including brain-controlled pneumatic gloves). Follow-up assessments will be conducted at 1, 2, 3 and 6 months after implantation to evaluate the safety and efficacy of the investigational medical device for upper-limb functional replacement in patients with tetraplegia caused by spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- "Triple-F" BCI
- Keywords
- BCI, Spinal Cord Injury
- 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.
"Triple-F" BCIDevice
Also called Fully implanted, wireless and functional BCI
Subjects will undergo implantation of the "Triple-F" BCI and receive standardized brain-computer interface training postoperatively, including training with brain-controlled pneumatic gloves. Follow-up visits will be scheduled at 1, 2, 3 and 6 months after implantation.
| Study group | Role | What they receive |
|---|---|---|
| "Triple-F" BCI | Experimental | Experimental: Implantation of the "Triple-F" BCI Receives: Device: "Triple-F" BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCI-assisted ARAT response rate (at 3 months postoperatively)
The proportion of subjects whose BCI-assisted ARAT score at 3 months postoperatively minus the baseline unassisted ARAT score at screening is ≥ the Minimal Clinically Important Difference (MCID).
Measured: 3 months post-operation
Secondary outcomes (10)
The ARAT score assessed with BCI assistance
The subject, wearing the pneumatic glove paired with the BCI system, performs the four ARAT subscales (grasp, grip, pinch, and gross motor) sequentially per standard procedures, with each subscale score and the total ARAT score recorded.The unabridged scoring sheet is titled the "Action Research Arm Test Scoring Sheet" . It yields a minimum score of 0 and a maximum score of 57 per arm (19 items scored 0-3 each), with higher scores indicating better outcomes, that is, better arm motor status.
Measured: 2, 3, and 6 months post-operation
ARAT score assessed without BCI assistance
The subject completes the assessment in accordance with the standard ARAT operating procedures without using the BCI-actuated pneumatic glove.The unabridged scoring sheet is titled the "Action Research Arm Test Scoring Sheet" . It yields a minimum score of 0 and a maximum score of 57 per arm (19 items scored 0-3 each), with higher scores indicating better outcomes, that is, better arm motor status.
Measured: baseline, 3 and 6 months post-operation
Task completion rate of five common hand-movement brain-control tasks
Measured: baseline，2，3 and 6 months post-operation
Success rate for six-direction target selection under brain control
Measured: 3 and 6 months post-operation
Change from baseline in Activities of Daily Living (ADL) score as measured by the Barthel Index
The Activities of Daily Living (ADL) Scale, commonly known as the Barthel Index, is scored using its original, unabridged form titled the "Barthel Index" , which comprises 10 items covering basic self-care and mobility, yielding a minimum total score of 0 (complete dependence) and a maximum of 100, with higher scores indicating better outcomes-that is, greater independence in activities of daily living.
Measured: baseline,2， 3 and 6 months post-operation
Change from baseline in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score
ISNCSCI are recorded on its standard worksheet titled the "International Standards for Neurological Classification of Spinal Cord Injury" (ASIA/ISNCSCI worksheet), in which sensory function is scored separately for light touch and pin prick (each ranging from a minimum of 0 to a maximum of 112 across 28 dermatomes bilaterally) and motor function is scored across 10 key muscle groups per side (yielding a total motor score from 0 to 100, with upper- and lower-extremity subscores of 0-50 each), with higher scores indicating better outcomes-that is, less neurological impairment after spinal cord injury.
Measured: baseline, 2，3 and 6 months post-operation
Reliability of the device
Under standardized conditions (with the subject at rest and room temperature ), the number of well-functioning channels of the implanted device is evaluated and recorded, together with the mean, median, minimum, and maximum impedance of the well-functioning channels and their trends over time. Impedance trends over time are presented as line graphs. Channels with an impedance not exceeding 1 MΩ are classified as well-functioning.
Measured: day of implantation，1,2,3 and6 months post-operation
Investigator-evaluated device operability performance
At the scheduled visits, the operating investigator rates the following performance items of the BCI compensation system using a pre-designed device performance evaluation form, graded on a four-level scale (excellent/good/fair/poor): signal acquisition stability, defined as the reliability and consistency of electrode signal recording; decoding response speed, defined as the latency from the generation of motor intention to the initiation of pneumatic glove movement; pneumatic glove output accuracy, defined as the degree of concordance between the movements actually performed by the glove and the decoded intentions; overall system stability, defined as the failure rate and system reliability during long-term use; wearing comfort and convenience, defined as the ease of donning the pneumatic glove and the subject's comfort while wearing it; and overall operational convenience, defined as the complexity of routine system operation and its user-friendliness.
Measured: 3 and 6 months post-operation
Subject-reported evaluation of device use
Assessment method: A subject device-use satisfaction questionnaire is administered; at the scheduled visits, the investigator reads each questionnaire item aloud to the subject, the subject responds verbally, and the investigator records the answers verbatim . The investigator must not guide or suggest the subject's answers in any way, and upon completion must confirm with the subject that the recorded responses are consistent with his or her own opinions. The questionnaire covers the following dimensions, each scored on a 5-point Likert scale with the following criteria: 5 = very satisfied / very easy, 4 = satisfied / relatively easy, 3 = neutral / neutral, 2 = dissatisfied / relatively difficult, 1 = very dissatisfied / very difficult. The dimensions include: wearing comfort, defined as the comfort of wearing the pneumatic glove in daily use; donning and doffing convenience, defined as the ease of putting on and taking off the pneumatic glove independent.
Measured: 3 and 6 months post-operation
Average time of device use per month
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 Jul 2026
- Study start7 Jul 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Apr 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroXess Technology (shanghai) Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720882
- Sponsor's protocol ID
- 2026-1015
- Acronym
- "Triple-F" BCI
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Target Value Clinical Trial to Evaluate the Efficacy and Safety of Implantable Brain-Computer Interface Hand Motor Function Compensation System for Upper-Limb Functional Replacement in Tetraplegic Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07720882
- Acronym / sponsor ID
- "Triple-F" BCI / 2026-1015
- Conditions
- Spinal Cord Injury
- Keywords
- BCI, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- NeuroXess Technology (shanghai) Co.,Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Jul 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 prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.
Detailed description
This trial adopts a prospective, multicenter, single-arm target value study design.
All enrolled subjects will receive implantation of an implantable brain-computer interface system for compensatory hand motor function, followed by standardized brain-computer training (including brain-controlled pneumatic gloves). Follow-up assessments will be conducted at 1, 2, 3 and 6 months after implantation to evaluate the safety and efficacy of the investigational medical device for upper-limb functional replacement in patients with tetraplegia caused by spinal cord injury.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Triple-F" BCI | Experimental | Device: "Triple-F" BCIExperimental: Implantation of the "Triple-F" BCI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years ≤ age ≤ 65 years, male or female;
- Cervical spinal cord injury (injury level C2-C6), with ASIA Impairment Scale grade A, B, or C;
- Severe impairment of hand function on the target upper extremity: finger flexor muscle strength < grade 3 as assessed by the ISNCSCI scale;
- ARAT score ≥ 2 for "hand to mouth"; score ≥ 1 for both "hand to top of head" and "hand to back of head"; and scores ≤ 1 for each of the grasp, grip, and pinch tasks;
- Neurological assessment confirms normal motor-related cortical function of the brain, with no acute cerebral functional changes;
Key exclusion criteria (15 listed)
- Neurodegenerative diseases / secondary injury due to tumors, or severe autonomic dysreflexia;
- Presence of intracranial lesions or contraindications to intracranial implantation: active epilepsy or definite epileptogenic tendency; severe cerebrovascular disease; brain tumor; moderate-to-severe sequelae of traumatic brain injury; space-occupying lesions or structural abnormalities at the electrode implantation target area; already implanted with active implantable electronic devices such as cardiac pacemakers/defibrillators, cochlear implants, deep brain stimulators, or drug infusion pumps, or presence of local metal foreign bodies/implants in the area to be implanted; or other contraindications to intracranial implantation as assessed by the investigator;
- Malignancies in other organ systems;
- Cardiovascular system diseases: severe cardiac insufficiency, severe arrhythmias, or uncontrolled hypertension;
- Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy, nasogastric tube feeding, etc.);
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 |
|---|---|---|
| "Triple-F" BCIAlso: Fully implanted, wireless and functional BCISubjects will undergo implantation of the "Triple-F" BCI and receive standardized brain-computer interface training postoperatively, including training with brain-controlled pneumatic gloves. Follow-up visits will be scheduled at 1, 2, 3 and 6 months after implantation. | Device | "Triple-F" BCI |
Primary outcome
BCI-assisted ARAT response rate (at 3 months postoperatively)
Time frame: 3 months post-operation
The proportion of subjects whose BCI-assisted ARAT score at 3 months postoperatively minus the baseline unassisted ARAT score at screening is ≥ the Minimal Clinically Important Difference (MCID).
10 secondary outcomes
The ARAT score assessed with BCI assistance
Time frame: 2, 3, and 6 months post-operation
ARAT score assessed without BCI assistance
Time frame: baseline, 3 and 6 months post-operation
Task completion rate of five common hand-movement brain-control tasks
Time frame: baseline，2，3 and 6 months post-operation
Success rate for six-direction target selection under brain control
Time frame: 3 and 6 months post-operation
Change from baseline in Activities of Daily Living (ADL) score as measured by the Barthel Index
Time frame: baseline,2， 3 and 6 months post-operation
Change from baseline in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score
Time frame: baseline, 2，3 and 6 months post-operation
Reliability of the device
Time frame: day of implantation，1,2,3 and6 months post-operation
Investigator-evaluated device operability performance
Time frame: 3 and 6 months post-operation
Subject-reported evaluation of device use
Time frame: 3 and 6 months post-operation
Average time of device use per month
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruitingObservational study
Risk Factors for Spinal Cord Injury After Minimally Invasive Aortic Repair
Spinal Cord Ischemia
Not yet recruiting
Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Functional Electrical Stimulation Plus High Intensity Interval Training at Home
Spinal Cord Injuries (SCI)
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.
Liang Chen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Triple-F" BCI in people with Spinal Cord Injury, run by NeuroXess Technology (shanghai) 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 9 inclusion and 15 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 Jul 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 Ying Mao, MD (+86 021 5288 8045, maoying@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCI-assisted ARAT response rate (at 3 months postoperatively) (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 Jul 2026.