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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

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ClinicalTrials.gov Identifier: NCT04474106
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Wolfgang Schaden, AUVA

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Traumatic Spinal Cord Injury Device: Shock waves Device: dummy head Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm three-stage adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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-blind, Placebo-controlled Clinical Trial
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ESWT
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
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.
Sham Comparator: Control
In the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head.
 Device: dummy head
The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves


Outcome Measures
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Primary Outcome Measures :
  1. changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline [ Time Frame: day 0 to 6 month ]
    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.


Secondary Outcome Measures :
  1. American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade [ Time Frame: day 0 to 6 month ]
    the AIS grade ranges from AIS A to AIS D, whereby AIS A are complete lesions and AIS B-D represent incomplete lesions

  2. degree of spasticity [ Time Frame: day 0 to 6 month ]
    self-rated degree of spasticity according to Penn Spasm Frequency Scale (PSFS); the scale ranges from 0 to 4, whereby 0 refers to no spasticity and 4 refers to more than 10 spasms per hour

  3. Walking ability (yes/no) [ Time Frame: day 0 to 6 month ]
    walking ability is being assessed using different walking tests as part of standard clinical routine: Walking Index for Spinal Cord Injury (WISCI) II, Timed up and go test (TUG), 10 Meter-Timed-Walk, 6 Minute-Walk-Test

  4. Urological function [ Time Frame: day 0 to 6 month ]

    Urological function will be assessed by several questions which should be answered with yes or no:

    • Permanent catheter: yes/no
    • Sensation of urinary bladder filling: yes/no
    • Documentation of the first attempt of bladder emptying: pos/neg, date
    • Self-catheterization: yes/no
    • Do you feel sensory innervation of the external genitalia (penis / labia)?
    • Do you feel the change of the catheter or manipulations on the catheter?
    • Do you feel the urge to defecate?
    • Do you feel stool evacuation?
    • Male patients: Have you had an erection since your injury?
    • Female patients: Have you felt sexually aroused since your injury?

  5. Plantar reflex (left/right: yes/no) [ Time Frame: day 0 to 6 month ]
    The plantar reflex (also called Babinski Test) will be performed separately on each foot to assess if pathological reflexes are present.

  6. Independence in everyday life [ Time Frame: day 0 to 6 month ]
    of patients is assessed with the Spinal Cord Independence Measure (SCIM II)

  7. adverse events (AEs) [ Time Frame: day 0 to 21 days ]
    The number of study related adverse events (AEs) are measured according to NCI CTCAE, version 5.0.

  8. Nine-Hole Peg Test (NHPT) (if feasible) [ Time Frame: day 0 to 6 month ]
    An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5

  9. Grasp and Release Test (GRT) [ Time Frame: day 0 to 6 month ]
    An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5

  10. Pinch grip: yes/no [ Time Frame: day 0 to 6 month ]
    An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5

  11. Clenched grip: yes/no [ Time Frame: day 0 to 6 month ]
    An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5

  12. Pencil grip: yes/no [ Time Frame: day 0 to 6 month ]
    An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5

  13. Lumbrical grip: yes/no [ Time Frame: day 0 to 6 month ]
    An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474106


Contacts
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Contact: Wolfgang Schaden, Dr 0043 5 9393 20170 wolfgang.schaden@auva.at
Contact: Iris Leister, MSc iris.leister@pmu.ac.at

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Richard Lindtner, Dr         
Contact: Rene Schmid, Dr.         
Rehazentrum Bad Häring Active, not recruiting
Bad Häring, Austria, 6323
Landeskarnkenhaus Feldkirch Recruiting
Feldkirch, Austria, 6807
Contact: Rene El-Attal, Prim         
Unfallkrankenhaus Graz Recruiting
Graz, Austria, 8020
Contact: Michael Plecko, Prim         
Rehazentrum Tobelbad Active, not recruiting
Graz, Austria, 8144
Rehazentrum Weißer Hof Active, not recruiting
Klosterneuburg, Austria, 3400
Unfallkrankenhaus Linz Recruiting
Linz, Austria, 4010
Contact: Klaus Katzensteiner, Prim.         
Universitätsklinik Linz, Neurochirurgie Traumatologie Not yet recruiting
Linz, Austria, 4020
Contact: Andreas Gruber, Prof. Dr.         
Unfallkrankenhaus Salzburg Recruiting
Salzburg, Austria, 5010
Contact: Alexander Schmelz, Prim.         
Universitätsklinik für Orthopädie und Traumatologie Not yet recruiting
Salzburg, Austria, 5020
Contact: Thomas Freude, Prof. Dr.         
Unfallkrankenhaus St. Pölten Not yet recruiting
St. Pölten, Austria, 3100
Contact: Hermann Schnell, Dr.         
Universitätsklinik Wien, AKH Recruiting
Wien, Austria, 1090
Contact: Stefan Hajdu, Prof.         
Unfallkrankenhaus Meidling Recruiting
Wien, Austria, 1120
Contact: Christian Fialka, Prim.         
Unfallkrankenhaus Lorenz Böhler Recruiting
Wien, Austria, 1200
Contact: Thomas Hausner, Prim         
SMZ Ost, Donauspital Abteilung für Unfallchirurgie Not yet recruiting
Wien, Austria, 1220
Contact: Medhi Mousavi, Prim         
Germany
Unfallkrankenhaus Berlin Not yet recruiting
Berlin, Germany, 12683
Contact: Andreas Niedeggen, Dr.         
Sponsors and Collaborators
AUVA
Investigators
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Principal Investigator: Wolfgang Schaden, Dr. AUVA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wolfgang Schaden, Deputy Medical Director of Austrian Workers´ Compensation Board (AUVA), AUVA
ClinicalTrials.gov Identifier: NCT04474106    
Other Study ID Numbers: NEUROwave
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System