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ACTIVE NOT RECRUITING
NCT04302259
NA

Intelligent Spine Interface, Clinical (ISI-C)

Sponsor: Rhode Island Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

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