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Intelligent Spine Interface, Clinical (ISI-C)
Sponsor: Rhode Island Hospital
Summary
This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs. This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface - Commercial, ISI-C) that will be implanted.
Official title: An Early Feasibility Study to Evaluate ISI-C in SCI Patients
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2021-09-01
Completion Date
2025-06-30
Last Updated
2025-03-10
Healthy Volunteers
No
Conditions
Interventions
Intelligent Spine Interface
ISI-C is a bi-directional, two anatomical location Epidural Electrical Stimulation (EES) system to bridge the lesion core in patients with chronic complete and incomplete spinal cord injury (SCI). This "Intelligent Spine Interface", or ISI will interpret recorded neural information from above a spinal cord lesion and transfer that information, via deep neural network-based interpreters (i.e. models), to stimulation sites (electrodes) below the lesion with the aim of restoring volitional control of the lower limb.
Locations (1)
Rhode Island Hospital
Providence, Rhode Island, United States