NCT04474106

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

Recruiting now NA Last updated 1 February 2024

What this trial tests

NA trial testing Shock waves in Acute Traumatic Spinal Cord Injury in 246 participants. Currently enrolling.

Timeline

2 July 2020

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	AUVA
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	246
Start date	2 July 2020
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	15 locations across Austria

Drugs / interventions tested

• Shock waves
• dummy head

Conditions studied

• Acute Traumatic Spinal Cord Injury — all drugs for Acute Traumatic Spinal Cord Injury →

Sponsor

AUVA — full company profile →

Who can join

Adults 18 to 99, any sex, with Acute Traumatic Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spinal cord injury: molecular mechanisms and therapeutic interventions.
   Hu X, Xu W, Ren Y, Wang Z, et al · · 2023 · cited 400× · PMID 37357239 · DOI 10.1038/s41392-023-01477-6
2. The effect of extracorporeal shock wave therapy in acute traumatic spinal cord injury on motor and sensory function within 6 months post-injury: a study protocol for a two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled clinical trial.
   Leister I, Mittermayr R, Mattiassich G, Aigner L, et al · · 2022 · cited 15× · PMID 35365190 · DOI 10.1186/s13063-022-06161-8
3. Effects of Extracorporeal Shockwave Therapy on Functional Recovery and Circulating miR-375 and miR-382-5p after Subacute and Chronic Spinal Cord Contusion Injury in Rats.
   Ashmwe M, Posa K, Rührnößl A, Heinzel JC, et al · · 2022 · cited 7× · PMID 35884935 · DOI 10.3390/biomedicines10071630
4. Current Preclinical and Clinical Evidence of Shock Wave Therapy for Spinal Cord Injury: A Systematic Review.
   Nagele S, Zellmer B, Graber M, Winter-Pölzl L, et al · · 2026 · PMID 42041555 · DOI 10.3390/cells15080687
5. The Effect of 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: A Two-Arm Three-Stage Adaptive, Prospective, Multi-Center, Randomized, Double-
   Leister I, Mittermayr R, Mattiassich G, Aigner L, et al · · 2021 · DOI 10.21203/rs.3.rs-320724/v1