Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBCIFlex Medical Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
IWBCIS
DeviceImplantable wireless brain-computer interface systems
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Implanted Brain-Computer InterfaceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Success rate of brain-controlled tasks
Time frame
2, 3, 6 months post-implantSecondary outcomes
1
Digital Instrumental Activities of Daily Living (dIADL)
Time frame
2, 3, 6 months post-implant2
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.
Time frame
2, 3, 6 months post-implant3
Patient Health Questionnaire-9 (PHQ-9)
Time frame
Baseline, 2, 3, 6 months post-implant4
Average Monthly Device Usage Duration
Time frame
6 months post-implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov