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The INSPIRE Study: Probable Benefit of the Neuro-spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02138110
Recruitment Status : Active, not recruiting
First Posted : May 14, 2014
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

Brief Summary:

This is an open-label, non-randomized, single-arm, multicenter study to evaluate safety and probable benefit of the Neuro-Spinal Scaffold in treating complete T2-T12 spinal cord injury.

This is a Humanitarian Device Exemption (HDE) Probable Benefit Study in support of future studies and an HDE application with subsequent approval.


Condition or disease Intervention/treatment Phase
Traumatic Thoracic Acute Spinal Cord Injury Device: Neuro-Spinal Scaffold Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold(TM) for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury
Study Start Date : April 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuro-Spinal Scaffold
Implantation of neuro-spinal scaffold in a cavity at the epicenter of the spinal cord contusion during open spine surgery.
Device: Neuro-Spinal Scaffold



Primary Outcome Measures :
  1. Proportion of Subjects With Improvement in AIS Grade of One or More Levels [ Time Frame: 6 months post-implant ]
    The number of subjects with positive change in AIS grade at the 6 month follow-up time point. The ISNCSCI exam performed within 8 hours prior to surgery was used as the reference time. .


Secondary Outcome Measures :
  1. Number of Subjects With Positive Change in ISNCSI Total Sensory Score. [ Time Frame: 6-months post-implant ]

    The number of subjects who showed improvement in sensory scores from baseline, determined by the ISNCSCI exam. The ISNCSCI exam performed within 8 hours prior to surgery was used as the reference time.

    A key point in each of the 28 dermatomes (from C2-S4/5) is tested bilaterally using light touch and pin-prick (sharp-dull discrimination). Appreciation of sensation is tested in comparison to sensation on the subject's cheek. A three-point scale is used for scoring:

    0 = absent

    1. = altered (impaired or partial appreciation, including hyperesthesia)
    2. = normal or intact (similar as on the cheek) NT = not testable The INSCSCI total sensory score is the sum of the pin prick score and the light touch score. maximum total of 56 points each for light touch and pin prick modalities, for a total of 112 points per side of the body.

    An increase in a score indicates a positive change in neurologic function while a decrease in score indicates a negative change in neurologic function.


  2. Number of Subjects With Positive Change in Motor Scores [ Time Frame: 6-months post-implant ]

    The number of subjects who showed improvement in motor scores from pre-implantation, determined by the ISNCSCI exam.

    Key muscle functions of the myotomes C5-T1 and L2-S1 are tested bilaterally. A six-point scales is used for scoring:

    0 = total paralysis

    1. = palpable or visible contraction
    2. = active movement, full range of motion (ROM) with gravity eliminated
    3. = active movement, full ROM against gravity
    4. = active movement, full ROM against gravity and moderate resistance in a muscle specific position
    5. = (normal) active movement, full ROM against gravity and full resistance in a muscle specific position expected from an otherwise unimpaired person 5* = (normal) active movement, full ROM against gravity and sufficient resistance to be considered normal if identified inhibiting factors (i.e., pain, disuse) were not present NT = not testable There is a maximum score of 25 for each extremity, totaling 50 for the upper limbs and 50 for the lower limbs.

  3. Number of Subjects With Positive Change in Neurological Level of Injury (NLI) [ Time Frame: 6 month post-implant ]

    Number of subjects showing a caudal change or improvement in NLI as compared to pre-implantation NLI, as determined by the ISNCSCI exam.

    The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally.


  4. Number of Subjects With no Change in Neurological Level of Injury (NLI) [ Time Frame: 6 month post-implant ]

    Number of subjects who showed no change in NLI at 6 months as compared to pre-implantation NLI, as determined by the ISNCSCI exam.

    The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally


  5. Number of Subjects With Negative Change in Neurological Level of Injury [ Time Frame: 6 month post-implant ]
    Number of subjects who showed a rostral change or deterioration in NLI at 6 months as compared to pre-implantation NLI, as determined by the ISNCSCI.

  6. Number of Subjects With Negative Change in ISNCSI Total Sensory Score. [ Time Frame: 6-months post-implant ]

    The number of subjects who demonstrated a deterioration in sensory pin prick score as compared to pre-implantation, in sensory scores from baseline, determined by the ISNCSCI exam.

    A key point in each of the 28 dermatomes (from C2-S4/5) is tested bilaterally using light touch and pin-prick (sharp-dull discrimination). Appreciation of sensation is tested in comparison to sensation on the subject's cheek. A three-point scale is used for scoring:

    0 = absent

    1. = altered (impaired or partial appreciation, including hyperesthesia)
    2. = normal or intact (similar as on the cheek) NT = not testable The INSCSCI total sensory score is the sum of the pin prick score and the light touch score. maximum total of 56 points each for light touch and pin prick modalities, for a total of 112 points per side of the body.

    An increase in a score indicates a positive change in neurologic function while a decre




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Aged 16 - 70 years
  • AIS A traumatic spinal cord injury at neurological spinal cord level T2-T12/L1
  • Recent injury (must receive Scaffold within 96 hours from injury)
  • Non-penetrating contusion injury no less than approximately 4 mm diameter by MRI

Key Exclusion Criteria:

  • Incomplete spinal cord injury (AIS B, C, D, E)
  • Terminally ill
  • Spinal cord injury associated with traumatic brain injury
  • Subject on long term mechanical ventilation
  • Penetrating injuries
  • Radiographic or visual evidence of parenchymal dissociation or anatomic transection where the contusion completely bridges a full cross-section of the spinal cord

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138110


Locations
United States, Arizona
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
USC/Keck School of Medicine
Los Angeles, California, United States, 90033
University of California/Davis Medical Center
Sacramento, California, United States, 95816
United States, Missouri
Barnes-Jewish Hospital at Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Neurological Institute
Camden, New Jersey, United States, 08103
United States, North Carolina
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28204
Vidant Medical Center
Greenville, North Carolina, United States, 27834
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
InVivo Therapeutics
Investigators
Study Director: Richard Toselli, MD InVivo Therapeutics
  Study Documents (Full-Text)

Documents provided by InVivo Therapeutics:
Statistical Analysis Plan  [PDF] January 17, 2018
Study Protocol  [PDF] June 30, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InVivo Therapeutics
ClinicalTrials.gov Identifier: NCT02138110     History of Changes
Other Study ID Numbers: InVivo-100-101
First Posted: May 14, 2014    Key Record Dates
Results First Posted: December 28, 2018
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by InVivo Therapeutics:
Spinal Cord Injury (SCI)
Complete (AIS A) Traumatic Acute Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System