Spinal Cord Injuries (SCI), Spinal Cord Injury Cervical, Tetraplegia/Tetraparesis
Conditions
Keywords
BCI, Tetraplegia, Spinal Cord Injuries (SCI)
Brief 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.
Interventions
DEVICEIWBCIS
Implantable wireless brain-computer interface systems
Sponsors
BCIFlex Medical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of brain-controlled tasks | 2, 3, 6 months post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digital Instrumental Activities of Daily Living (dIADL) | 2, 3, 6 months post-implant | — |
| Brain Control Fluency Index | 2, 3, 6 months post-implant | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, 2, 3, 6 months post-implant | — |
| Average Monthly Device Usage Duration | 6 months post-implant | — |
| WHO Quality of Life BREF | Baseline, 2, 3, 6 months post-implant | — |
| Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) | Baseline, 2, 3, 6 months post-implant | — |
| Psychosocial Impact of Assistive Devices Scale (PIADS) | 2, 3, 6 months post-implant | — |
| Subject Satisfaction with the Device | 2, 3, 6 months post-implant | Trial subject report questionnaire to measure the trial subject's satisfaction of using trial device. |
| Investigator Satisfaction with Device Operation | 2, 3, 6 months post-implant | Investigator report questionnaire to measure the investigator's satisfaction with device operation. |
| Device Reliability | up to 6 months post-implant | Device Reliability is measure by the Electrode Impedance of the Device |
Countries
China
Contacts
CONTACTBCIFlex
Outcome results
None listed