An interventional study of "Triple-F" BCI in Spinal Cord Injury, sponsored by NeuroXess Technology (shanghai) Co.,Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by NeuroXess Technology (shanghai) Co.,Ltd. · Not applicable, Interventional, and Other
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 32 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with NeuroXess Technology (shanghai) Co.,Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental: Implantation of the "Triple-F" BCI
Device: "Triple-F" 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.
Also known as: Fully implanted, wireless and functional BCI
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).
Time frame: 3 months post-operation
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 and 6 months post-operation
Average time of device use per month
Time frame: 3 and 6 months post-operation
Plan to share: Undecided
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