Intelligent Spine Interface (ISI)

An Early Feasibility Study to Evaluate ISI-C in SCI Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Intelligent Spine Interface

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jared S Fridley, MD; Phone Number: 401-793-9197; Email: jared.fridley@lifespan.org
• Study Contact Backup: Name: Owen Leary, BS; Phone Number: 401-606-8388; Email: owen.leary@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Owen Leary, BS; Phone Number: 401-444-4362; Email: spinalcordstudy@lifespan.org
      • Contact: Alexander Chernysh, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Adults (men or women) between the ages of 18 and 65 years old

  • Complete or Incomplete SCI with AIS grade of A or B between the levels of C7/T1 and T10 (level and degree of injury based on the international standards for neurological classification of SCI (ISNCSCI))
  • Focal area of SCI due to trauma
  • SCI date of injury > 1 year prior to enrollment
  • Completed prior SCI rehabilitation program
  • Ability to use both upper extremities to ambulate with a wheelchair or crutches
  • Distance between the conus medullaris and site of injury must be > 4 cm
  • The ability to participate in intensive physical therapy and research > 4 hours per day for 2 weeks
  • Must provide informed consent prior to study participation

Exclusion Criteria:

• • Presence of co-existing lower extremity neuropathy or disorders of the cauda equina

  • Presence of non-traumatic spinal cord pathology
  • Significant cognitive impairment or decreased level of consciousness
  • Presence of an intrathecal baclofen or morphine pump
  • Presence of a cardiac defibrillator or pacemaker
  • Presence of a deep brain stimulator device
  • Patient who has any contraindication to having a MRI performed
  • Severe or disabling joint contractures in the lower extremities
  • Presence of hematologic disorder or medication related coagulopathy that would preclude surgery
  • Lower extremity congenital or acquired deformities
  • Women who are pregnant or who are unwilling to use contraception during the study period
  • Body mass index > 30
  • Cardiopulmonary comorbidities that preclude participation in intensive physical therapy
  • Known or suspected patient non-compliance during the study period and at follow up
  • Patient life expectancy < 12 months
  • Presence of patient comorbidities or spinal anatomy that would preclude participation in the study per investigators' recommendation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SCI Patient; Complete or Incomplete Spinal Cord Injury (SCI) patients with Asia Impairment Score (AIS) of A or B between the levels of C7/T1 and T10

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.; Other Names: spinal neuromodulation therapy, spinal cord stimulation device, epidural electrical stimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate safety issues	Evaluate safety issues associated with the implantation and use of ISI technology i.e. frequency of device related adverse events	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological Outcome Measures	Assess neurological outcomes before, during, and after ISI implantation in SCI patients via ISNCSCI evaluation	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via 6 Minute Walk Test	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via 10 minute timed walk test	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via Time Up and Go test	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via Spinal cord Injury Functional Ambulation Inventory	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via Spinal Cord Injury Quality of Life (SCI-QOL): Ambulation Short Form	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via SCI Functional Ambulatory Inventory (FAI)	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via Berg Balance Scale	8 months
Functional Outcome Measures	Assess functional outcomes before, during, and after ISI implantation in SCI patients via Mini-Best test	8 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Brown University; US Department of Veterans Affairs; Boston Scientific Corporation; Intel Corporation; Nuvectra
• Investigators: Principal Investigator: David Borton, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 001020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes