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

Source: ClinicalTrials.gov · Trial registry · Not peer reviewed · real data

Published: 2014-10-13

The injury this work is about

The phase, the band and the outcomes this paper's studies were recorded under, explained in plain words.

Open this plate

The cord in cross-section at reading size: butterfly-shaped grey matter with its dorsal, lateral and ventral horns; white matter around it; the groove behind and the fissure in front; the sensory rootlets entering behind through their ganglion and the motor rootlets leaving in front, joining as one spinal nerve that then divides. Two arrows: sensation in, movement out.
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Plate 3Atlas of a spinal cord injury3of 19Insidethe cordBackThe cord in cross-section at reading size: butterfly-shaped grey matter with its dorsal, lateral and ventral horns; white matter around it; the groove behind and the fissure in front; the sensory rootlets entering behind through their ganglion and the motor rootlets leaving in front, joining as one spinal nerve that then divides. Two arrows: sensation in, movement out.White matterWhite matterDorsal rootDorsal rootDorsal hornDorsal hornDorsal root ganglionDorsal root ganglionThe cross-sectionThe cross-sectionFrontVentral hornVentral hornVentral rootVentral rootLateral hornLateral hornSpinal nerveSpinal nerveGrey matterGrey matter

What is being changed here, drawn

Inside the cord

The butterfly-shaped centre. Nerve cell bodies sit here: the signal arrives, is processed, and a command leaves.

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  • The meningesThree layers around the cord — dura, arachnoid and pia mater. Between them is fluid that works as a cushion.
  • Cervical regionEight segments, C1–C8. The nerves to the diaphragm, the shoulders and the arms leave from here.
  • Lumbar regionFive segments, L1–L5. The nerves to the hips and legs leave from here.
  • The cross-sectionCut across, the cord shows butterfly-shaped grey matter in the middle and white matter around it. That arrangement is why one injury at one level affects different functions differently.
  • Grey matterThe butterfly-shaped centre. Nerve cell bodies sit here: the signal arrives, is processed, and a command leaves.
  • Dorsal hornThe back part of the butterfly. Sensory information from the body arrives here.
  • Ventral hornThe front part of the butterfly. The motor neurons that drive muscles directly sit here.
  • Dorsal rootThe bundle of fibres entering the cord from behind, carrying sensation from the body inward.

Identifiers

  • NCT number: NCT02138110

Claims this paper bears on

  • Partially supports — Implantation of a bioresorbable polymer scaffold into the injured spinal cord is associated with serious adverse events.
  • Partially supports — An implanted bioresorbable polymer scaffold improves sensory function after spinal cord injury.
  • Partially supports — An implanted bioresorbable polymer scaffold improves neurological grade conversion after spinal cord injury.

Results extracted

ResultLocation in the sourceQuotation
Tissue integrity · Secondary, pre-specified[results]SECONDARY · Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence) · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 1
Outside our vocabulary · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 5
Outside our vocabulary · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 5 Neuro-Spinal Scaffold: 8
Outside our vocabulary · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 5 Neuro-Spinal Scaffold: 8 Neuro-Spinal Scaffold: 3
Sensory function · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 10
Sensory function · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 10 Neuro-Spinal Scaffold: 6
Sensory function · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 10 Neuro-Spinal Scaffold: 6 Neuro-Spinal Scaffold: 0
Sensory function · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 10
Motor function · Primary, pre-specifiedresultsPRIMARY · Percentage of Patients With Improvement in AIS Grade of One or More Levels · unit: percentage of patients · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 44
Sensory function · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 10 Neuro-Spinal Scaffold: 4 Neuro-Spinal Scaffold: 2
Motor function · Secondary, pre-specifiedresultsSECONDARY · Change From Baseline in ISNCSCI Total Motor Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 1
Motor function · Secondary, pre-specifiedresultsSECONDARY · Change From Baseline in ISNCSCI Total Motor Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 1 Neuro-Spinal Scaffold: 0
Motor function · Secondary, pre-specifiedresultsSECONDARY · Change From Baseline in ISNCSCI Total Motor Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 1 Neuro-Spinal Scaffold: 0 Neuro-Spinal Scaffold: 14
Tissue integrity · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence) · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 9
Tissue integrity · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence) · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 9 Neuro-Spinal Scaffold: 5
Tissue integrity · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence) · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 9 Neuro-Spinal Scaffold: 5 Neuro-Spinal Scaffold: 2
Sensory function · Secondary, pre-specifiedresultsSECONDARY · Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score · unit: Participants · measured at: 6 months post-implantation Neuro-Spinal Scaffold: 10 Neuro-Spinal Scaffold: 4

Study

  • NCT02138110/brief_summary human

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