ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02138110
Recruitment Status : Active, not recruiting
First Posted : May 14, 2014
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

Brief Summary:
  • To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury .
  • This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate safety and probable benefit 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 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Neuro-Spinal Scaffold 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 ]
    A preset objective performance criterion (OPC) based upon this proportion will be used as the primary measure of success for this study.


Secondary Outcome Measures :
  1. Proportion of subjects with improvement in motor scores [ Time Frame: 6 months ]
  2. Proportion of subjects with improvement in sensory scores [ Time Frame: 6 months ]
  3. Proportion of subjects with improvement in hip abduction/adduction or great toe flexion/extension [ Time Frame: 6 months ]
  4. Proportion of subjects with improvement in bowel function [ Time Frame: 6 months ]
  5. Proportion of subjects with improvement in bladder function [ Time Frame: 6 months ]
  6. Proportion of subjects with improvement in SCIM III [ Time Frame: 6 months ]
  7. Proportion of subjects with improvement in QLI-SCI III [ Time Frame: 6 months ]
  8. Proportion of subjects with decreased pain [ Time Frame: 6 months ]
  9. Incidence of all Adverse Device Effects of any kind/seriousness. [ Time Frame: 6 months ]


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, Senior)
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

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
Last Update Posted: March 16, 2018
Last Verified: March 2018

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