Status:
RECRUITING
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
Lead Sponsor:
AUVA
Conditions:
Acute Traumatic Spinal Cord Injury
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 init...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04474106
Start Date
July 2 2020
End Date
December 31 2026
Last Update
February 1 2024
Active Locations (15)
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1
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
2
Rehazentrum Bad Häring
Bad Häring, Austria, 6323
3
Landeskarnkenhaus Feldkirch
Feldkirch, Austria, 6807
4
Unfallkrankenhaus Graz
Graz, Austria, 8020