This is a trial to test the effect of a device called the Bidirectional Neural Bypass System on hand and wrist movement and sensation in individuals with chronic complete tetraplegia after high cervical SCI. If included in this trial, the participant will first receive neurological examinations and brain scans (functional magnetic resonance image (fMRI) and diffusion tensor image (DTI)). If eligible for continued participation, the participant will undergo surgery to implant electrodes into the brain, which can record brain activity and deliver stimulation to specific brain areas. After surgical recovery, the participant will undergo an X-Ray computed tomography (CT) scan and will be discharged from the hospital. After full recovery, the participant will attend 3x4-hour study sessions a week for 12 months to test hand and wrist movement and sensation. This trial does not have a control group.
Traumatic
Type
Details
First stage: The first visit includes a neurological examination and a brain scan (functional magnetic resonance image (fMRI) and diffusion tensor image (DTI)). Second stage: The participant will undergo surgery to implant the electrodes into the brain. During surgical recovery, the participant will have an X-Ray CT Scan and then discharged from the hospital. Third stage: 3 x 4-hour sessions a week for 12 months to test hand and wrist function.
Main benefits
General health
Additional benefits
Arm/hand function
Sensory function
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn moreWings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more