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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Implantable wireless brain-computer interface systems
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
RECRUITINGSuccess rate of brain-controlled tasks
Time frame: 2, 3, 6 months post-implant
Digital Instrumental Activities of Daily Living (dIADL)
Time frame: 2, 3, 6 months post-implant
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-implant
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 2, 3, 6 months post-implant
Average Monthly Device Usage Duration
Time frame: 6 months post-implant
WHO Quality of Life BREF
Time frame: Baseline, 2, 3, 6 months post-implant
Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Time frame: Baseline, 2, 3, 6 months post-implant
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: 2, 3, 6 months post-implant
Subject Satisfaction with the Device
Trial subject report questionnaire to measure the trial subject's satisfaction of using trial device.
Time frame: 2, 3, 6 months post-implant
Investigator Satisfaction with Device Operation
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Investigator report questionnaire to measure the investigator's satisfaction with device operation.
Time frame: 2, 3, 6 months post-implant
Device Reliability
Device Reliability is measure by the Electrode Impedance of the Device
Time frame: up to 6 months post-implant