Intelligent Spine Interface, Clinical (ISI-C)

NCT04302259 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 001020
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 - Commercial, ISI-C) that will be implanted.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Neurological Outcome Measures

  8 months

• Functional Outcome Measures

  8 months

• Functional Outcome Measures

  8 months

• Functional Outcome Measures

  8 months

• Functional Outcome Measures

  8 months

Study Arms (1)

SCI Patient

EXPERIMENTAL

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

Interventions

Intelligent Spine Interface DEVICE

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.

Also known as: spinal neuromodulation therapy, spinal cord stimulation device, epidural electrical stimulation system

SCI Patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• US Department of Veterans Affairs: collaborator
• Brown University: collaborator
• Intel Corporation: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Borton, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 10, 2020
• Study Start: September 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)