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

NCT04474106 | Recruiting DMC

• 1 other identifier: NEUROwave
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 15

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 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.

Conditions

Acute Traumatic Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline

  greater improvement in motor and sensory function (the AIS grade) can be achieved in patients after spinal trauma (AIS A-D) by applying a single extracorporeal shockwave therapy compared to the control group.

  day 0 to 6 month

Secondary Outcomes (13)

• American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade

  day 0 to 6 month

• degree of spasticity

  day 0 to 6 month

• Walking ability (yes/no)

  day 0 to 6 month

• Urological function

  day 0 to 6 month

• Plantar reflex (left/right: yes/no)

  day 0 to 6 month

Study Arms (2)

ESWT

EXPERIMENTAL

The extracorporeal shockwave therapy is applied once at the level of lesion and 5 segments above and below; or below the occiput (in lesions higher than C6) and above the sacrum (in lesions lower than T12). In addition, the ESWT is applied to the soles of both feet on the medial side of the plantar surface. The ESWT is applied as soon as possible within 48 hours post-injury.

Device: Shock waves

Control

SHAM COMPARATOR

In the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head.

Device: dummy head

Interventions

Shock waves DEVICE

The shockwave generator orthogold 100® generates high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, Spark Waves® can easily travel great distance as long as the acoustic impedance stays the same.

ESWT

dummy head DEVICE

The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AUVA: lead

Study Sites (15)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Rehazentrum Bad Häring

Bad Häring, 6323, Austria

ACTIVE NOT RECRUITING

Landeskarnkenhaus Feldkirch

Feldkirch, 6807, Austria

RECRUITING

Unfallkrankenhaus Graz

Graz, 8020, Austria

RECRUITING

Rehazentrum Tobelbad

Graz, 8144, Austria

ACTIVE NOT RECRUITING

Unfallkrankenhaus Klagenfurt

Klagenfurt, 9020, Austria

RECRUITING

Rehazentrum Weißer Hof

Klosterneuburg, 3400, Austria

ACTIVE NOT RECRUITING

Unfallkrankenhaus Linz

Linz, 4010, Austria

RECRUITING

Unfallkrankenhaus Salzburg

Salzburg, 5010, Austria

RECRUITING

Universitätsklinik für Orthopädie und Traumatologie

Salzburg, 5020, Austria

WITHDRAWN

Unfallkrankenhaus St. Pölten

Sankt Pölten, 3100, Austria

WITHDRAWN

Universitätsklinik Wien, AKH

Vienna, 1090, Austria

RECRUITING

Unfallkrankenhaus Meidling

Vienna, 1120, Austria

RECRUITING

Unfallkrankenhaus Lorenz Böhler

Vienna, 1200, Austria

WITHDRAWN

SMZ Ost, Donauspital Abteilung für Unfallchirurgie

Vienna, 1220, Austria

NOT YET RECRUITING

Related Publications (1)

• Leister I, Mittermayr R, Mattiassich G, Aigner L, Haider T, Machegger L, Kindermann H, Grazer-Horacek A, Holfeld J, Schaden W. 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. Trials. 2022 Apr 1;23(1):245. doi: 10.1186/s13063-022-06161-8.

  PMID: 35365190 DERIVED

Study Officials

• Wolfgang Schaden, Dr.

  AUVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Schaden, Dr

CONTACT

0043 5 9393 20170; wolfgang.schaden@auva.at

Iris Leister, MSc

CONTACT

iris.leister@pmu.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stratified block randomization with a block size of four and a 1:1 allocation will be used to assign participants to one of two groups (treatment vs. placebo). Three neurological levels of injury will be used for stratification.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Medical Director of Austrian Workers´ Compensation Board (AUVA)

Model Details: Two-arm three-stage adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 16, 2020
• Study Start: July 2, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

AU (15)