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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

RecruitingNAAges 18 Years - 99 YearsAllAUVA
NCT04474106 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with acute traumatic spinal injuries who are awake, responsive, and oriented at 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 the Austrian hospitals) Exclusion Criteria: * Patients who cannot cooperate or are not capable to give consent to participate * Serious traumatic brain injuries that prevent accurate participation in study procedures and/or adequacy of informed consent Participation in other interventional clinical trials * Serious concomitant injuries that prevent the neurological initial assessment * Preexisting neurological conditions that affect the primary endpoint of the study and potentially 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
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What it tests

  • Shock waves
  • dummy head
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Where

15 sites
Medical University Innsbruck
Innsbruck, Austria
Rehazentrum Bad Häring
Bad Häring, Austria
Landeskarnkenhaus Feldkirch
Feldkirch, Austria
Unfallkrankenhaus Graz
Graz, Austria
Rehazentrum Tobelbad
Graz, Austria
Unfallkrankenhaus Klagenfurt
Klagenfurt, Austria
Rehazentrum Weißer Hof
Klosterneuburg, Austria
Unfallkrankenhaus Linz
Linz, Austria

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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