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Neuroprosthetic Device
Neuro-Spinal Scaffold™ for Spinal Cord Injury (INSPIRE 2 Trial)
N/A
Waitlist Available
Research Sponsored by InVivo Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Awards & highlights
INSPIRE 2 Trial Summary
This trial will compare a new neuro-spinal scaffold to standard care for treating complete spinal cord injuries. The scaffold is designed to be a safe and probable benefit for patients.
Who is the study for?
This trial is for individuals aged 16-70 with a recent, severe spinal cord injury (T2-T12 level) confirmed by MRI. They must be stable before surgery and not have penetrating injuries or other significant neurological conditions. Pregnant women, those unwilling to use birth control post-surgery, and people with certain infections or hypersensitivities are excluded.Check my eligibility
What is being tested?
The study tests the Neuro-Spinal Scaffold's safety and potential benefits in treating complete thoracic spinal cord injuries compared to standard care. Participants will either receive the scaffold implant during open spine surgery or undergo standard surgical care without it.See study design
What are the potential side effects?
While specific side effects of the Neuro-Spinal Scaffold aren't detailed here, typical risks may include infection at the surgery site, inflammation, pain or discomfort from the implant, possible allergic reactions to materials used in the scaffold.
INSPIRE 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in AIS grade of one or more levels
Secondary outcome measures
Change in Neurological Level of Injury (NLI)
Change in motor scores
Change in sensory scores
+7 moreINSPIRE 2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Neuro-Spinal Scaffold ArmExperimental Treatment1 Intervention
Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery.
Group II: Comparator ArmActive Control1 Intervention
Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold.
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Who is running the clinical trial?
InVivo TherapeuticsLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a spinal cord injury that is not complete (AIS B, C, D, or E injuries).You have more than one separate spinal cord injury.The injured spinal cord does not have a specific empty space where a Scaffold can be inserted.There is clear and strong nerve activity detected at the injury site, as determined by the doctor.You have significant existing neurological problems that are not related to the injury being treated.You have a history of serious mental illness.You are allergic to PLGA or PLL.You have a serious brain injury that would make it hard to accurately check your spinal cord function.You have a known immune deficiency disorder, such as HIV/AIDS.You have recently been diagnosed with a narcotics or substance abuse problem.You have a complete spinal cord injury as shown on the screening MRI.You have a spinal cord injury caused by being shot, stabbed, or other penetrating wounds.You have a specific type of spinal cord injury between the T2 and T12 levels, as confirmed by a qualified doctor.You have a serious lung disease not related to the injury being treated.You need a machine to help you breathe for a long time.You have an ongoing infection before the injury.You have a spinal cord injury that is not caused by something piercing your skin and is at least about 4 millimeters wide when seen on an MRI.You must be between 16 and 70 years old.You have a very high body mass index (BMI).You are currently taking tetracycline medications like minocycline.You had spine surgery within the past 7 days.You have a score of 45 or less on the Injury Severity Scale at the time of screening.You must have a Glasgow Coma Scale (GCS) score of at least 14 (or at least 10 if you are on a breathing machine) when screened, and a GCS score of 15 (or at least 10 if you are on a breathing machine) within two hours before spine surgery.You need to have surgery on your spine that allows doctors to reach the injured spinal cord, either from the back or from both the back and the front.
Research Study Groups:
This trial has the following groups:- Group 1: Neuro-Spinal Scaffold Arm
- Group 2: Comparator Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT03762655 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment open to me?
"This research requires the enrolment of 20 persons aged between 16 and 70 suffering from a traumatic spinal cord injury classified AIS A. The patient must have recently undergone spine surgery (within 7 days) with an Injury Severity Score not exceeding 45, as well pass a Glasgow Coma Scale assessment obtaining GCS ≥ 10 for intubated subjects at screening time and prior to surgery. Furthermore, their SCI must be non-penetrating (>4 mm MRI), require open spine surgery granting access to the injured area, plus 8 hours of hemodynamic stability post-surgery before enrollment. Informed consent is also compulsory."
Answered by AI
At what number of locations can this medical trial be conducted?
"Currently, this clinical trial is being conducted at 18 medical centres across the United States. Notable sites include Philadelphia, Portland and Boston. To minimize travel time for participants it is advisable to select a location that is closest to you when enrolling in the program."
Answered by AI
Is enrollment currently open for this research project?
"According to clinicaltrials.gov, this medical trial is no longer recruiting participants. It was initially advertised on May 21st 2019 and last edited on June 2nd 2022. However, there are currently 913 different studies that require patient recruitment."
Answered by AI
Do applicants over the age of 70 qualify for inclusion in this project?
"This clinical trial will accept individuals aged 16 and above but younger than 70."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
Florida
Colorado
How old are they?
18 - 65
What site did they apply to?
UC Davis Medical Center
University of Colorado Memorial Hospital Central
University of South Florida Health Neurosurgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to be in better shape than I am. Looking to try new treatment plans in order to walk again in the future.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Is there a payment for the screening?
PatientReceived 2+ prior treatments
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