Intelligent Spine Interface, Clinical (ISI-C)

Intel Corporation, Nuvectra 18. US FDA Regulated: Yes 19. US FDA Regulated Drug: No 20. US FDA Regulated Device: Yes 21. US FDA Investigational New Device (IND)/Investigational Device Exemption (IDE): Yes 22. Human Subjects Protection Review: Pending Review 23. Data Monitoring Committee: Yes 24. FDA Regulated Intervention: Yes

25. Brief 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) that will be implanted.

26. Detailed Description:

The investigators propose to build an Intelligent Spine Interface (ISI) that will interpret neural information from above a spinal cord injury and transfer that information, via a state-of-the-art artificial neural network-based computer interpreter, to sites below the site of injury and restore control of the lower limbs.

At present, activity-based therapies (physical rehabilitation) are only medical practices that can be used to enhance recovery after spinal cord injury. However, most affected patients, who fail to produce active movements voluntarily, experience minimal benefits from such therapies.

This study is being done to develop a new treatment modality 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.

The device being used in this study is termed Intelligent Spine Interface. This device consists of: (1) surgically implanted electrode arrays placed above and below site of spinal cord injury. These arrays are connected to other device components outside the body (like "Ripple System") using specialized wires. (2) "Ripple System" collects readings from implanted electrode arrays. Together, these components are used to stimulate the spinal cord and sense any resulting nervous system signals. (3) Personal computer uses specialized software to interpret the nervous system activity.

The use of the ISI-C device in this study is considered investigational. This means the device has not yet been approved by the FDA.

The entire study should take about 7-8 months to complete.

Study Phases and Procedures:

• Screening Phase: Subject identification, consent process, eligibility review, preliminary assessments (imaging studies such as x-rays, blood work, physical/neurological exam, medical history, medication review, pregnancy test, electrocardiogram to assess heart health)
• Pre-rehabilitation Phase: baseline review of SCI related standardized outcome measures to understand if the device/treatment is producing the desired effect on the participant physical function (e.g. gait, balance, ability to walk, muscle tone/spasm, bowel function).
• Surgery: Pre-surgery testing, anesthesia administration, lead placement above and below the site of injury, wound closure and observation
• Inpatient Rehabilitation Phase: daily physical rehabilitation sessions in specialized gaits lab, neurostimulation protocol (small electrical pulses will be delivered to the implanted electrode array and any spinal cord activity will be recorded), follow-up SCI-related outcome measures review
• Surgery: same as above - surgically implanted leads will be removed
• Follow up phase: Follow-up physical and neurological exams to assess if there is a change in function since baseline