NEUROwave - Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury

Last updated: January 31, 2024
Sponsor: AUVA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Shock waves

dummy head

Clinical Study ID

NCT04474106
NEUROwave
  • Ages 18-99
  • All Genders

Study Summary

It has been hypothesized that there are two mechanisms of acute traumatic spinal cord injury (SCI): the primary mechanical damage and the secondary injury due to additional pathological processes initiated by the primary injury. Neurological damage due to laceration, contusion, distraction or compression of the spinal cord is called ''primary injury''. This mechanical injury leads to a cascade of biochemical and pathological changes, described as ''secondary injury'', which occurs minutes to weeks after the initial trauma and causes further neurological deterioration. This secondary cascade involves vascular changes, an inflammatory response, neurotoxicity, apoptosis and glial scarring, and further compromises neurological impairment after traumatic spinal cord injury. Edema, ischemia and loss of autoregulation continue to spread bi-directionally from the initial lesion along the spinal cord for up to 72 hours after the trauma.

It has been postulated that the damage caused by the primary injury mechanism is irreversible and therapeutic approaches in recent years have focused on modulating the secondary injury cascade.

Researchers found significantly greater numbers of myelinated fibers in peripheral nerves after a single ESWT application in an experimental model on rats after a homotopic nerve autograft into the sciatic nerve.

In another study a spinal cord ischemia model in mice was performed. ESWT was applied immediately after surgery and the treated animals showed a significantly better motor function and decreased neuronal degeneration compared to the control group within the first 7 days after surgery.

Researchers investigated the effect of low-energy ESWT for the duration of three weeks on a thoracic spinal cord contusion injury model in rats. Animals in the ESWT group demonstrated significantly better locomotor improvement and reduced neuronal loss compared to the control animals at 7, 35, and 42 days after contusion.

It has been postulated previously, that ESWT improves the metabolic activity of various cell types and induces an improved rate of axonal regeneration.

ESWT might be a promising therapeutic strategy in the treatment of traumatic SCI.

The underlying study aims to investigate the effect of ESWT after acute traumatic spinal cord injury in humans within 48 hours of trauma in order to intervene in the secondary injury phase with the objective to reduce the extent of neuronal damage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with acute traumatic spinal injuries who are awake, responsive, and orientedat admission
  • Patients from the age of 18 years
  • Admission to hospital within 24 hours after injury
  • Written consent to participate in the study
  • Participation in the Austrian Spinal Cord Injury Study (ASCIS)-Registry (only for theAustrian hospitals)

Exclusion

Exclusion Criteria:

  • Patients who cannot cooperate or are not capable to give consent to participate
  • Serious traumatic brain injuries that prevent accurate participation in studyprocedures and/or adequacy of informed consent Participation in other interventionalclinical trials
  • Serious concomitant injuries that prevent the neurological initial assessment
  • Preexisting neurological conditions that affect the primary endpoint of the study andpotentially mask or reduce the therapeutic effect of the ESWT application
  • High dose administration of corticosteroids
  • Complete spinal cord transection
  • Patients with pacemakers or implantable defibrillators
  • Patients who are using devices which are sensitive to electromagnetic radiation
  • (potential) Pregnancy
  • Patients with tumors
  • Patients with severe coagulation disorders

Study Design

Total Participants: 246
Treatment Group(s): 2
Primary Treatment: Shock waves
Phase:
Study Start date:
July 02, 2020
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Medical University Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Active - Recruiting

  • Rehazentrum Bad Häring

    Bad Häring, 6323
    Austria

    Site Not Available

  • Landeskarnkenhaus Feldkirch

    Feldkirch, 6807
    Austria

    Active - Recruiting

  • Rehazentrum Tobelbad

    Graz, 8144
    Austria

    Site Not Available

  • Unfallkrankenhaus Graz

    Graz, 8020
    Austria

    Active - Recruiting

  • Unfallkrankenhaus Klagenfurt

    Klagenfurt, 9020
    Austria

    Active - Recruiting

  • Rehazentrum Weißer Hof

    Klosterneuburg, 3400
    Austria

    Site Not Available

  • Unfallkrankenhaus Linz

    Linz, 4010
    Austria

    Active - Recruiting

  • Universitätsklinik Linz, Neurochirurgie Traumatologie

    Linz, 4020
    Austria

    Site Not Available

  • Unfallkrankenhaus Salzburg

    Salzburg, 5010
    Austria

    Active - Recruiting

  • Universitätsklinik für Orthopädie und Traumatologie

    Salzburg, 5020
    Austria

    Site Not Available

  • Unfallkrankenhaus St. Pölten

    St. Pölten, 3100
    Austria

    Site Not Available

  • SMZ Ost, Donauspital Abteilung für Unfallchirurgie

    Wien, 1220
    Austria

    Site Not Available

  • Unfallkrankenhaus Lorenz Böhler

    Wien, 1200
    Austria

    Site Not Available

  • Unfallkrankenhaus Meidling

    Wien, 1120
    Austria

    Active - Recruiting

  • Universitätsklinik Wien, AKH

    Wien, 1090
    Austria

    Active - Recruiting

  • Unfallkrankenhaus Berlin

    Berlin, 12683
    Germany

    Site Not Available

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