Intelligent Spine Interface, Clinical (ISI-C)
About this trial
This study is enrolling individuals with chronic spinal cord injuries to study an electrical stimulation device intended to improve voluntary leg function. The device (Intelligent Spine Interface-Commercial; ISI-C) is implanted around the injured spinal cord to transfer recorded nerve signals from above the spinal cord lesion to electrodes below the lesion. Researchers want to see if the ISI device affects voluntary leg movement. This study hopes to understand how nervous system signals travel within the spinal cord, and then to develop a device that can restore volitional control of lower limbs. The study will collect data on safety, leg function (strength, walking) and balance, over 8 months. If selected for the trial, participants will receive imaging studies (e.g. X-rays, etc.), surgery to implant the ISI device, and will receive physical rehabilitation.
Included participants
Traumatic
What’s involved
Type
Details
Surgical implantation of a portion of the electrical stimulation device Imaging studies (e.g. X-rays etc.) Physical rehabilitation Various assessments of safety, leg function (strength, walking) and balance
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
General health
Mental health and psychosocial factors
Sensory function
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
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 more- Trial recruitment status
- Active
- Trial start date
- 1 Sep 2021
- Organisation
- Rhode Island Hospital
- Trial recruitment status
- Active
- Trial start date
- 1 Sep 2021
- Organisation
- Rhode Island Hospital
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
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 more