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

Acute Traumatic Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474106
• Other study ID #: NEUROwave
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: AUVA
• Contact: Wolfgang Schaden, Dr
• Phone: 0043 5 9393 20170
• Email: wolfgang.schaden[@]auva.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Traumatic Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Austria	Rehazentrum Bad Häring	Bad Häring
Austria	Landeskarnkenhaus Feldkirch	Feldkirch
Austria	Rehazentrum Tobelbad	Graz
Austria	Unfallkrankenhaus Graz	Graz
Austria	Medical University Innsbruck	Innsbruck	Tirol
Austria	Unfallkrankenhaus Klagenfurt	Klagenfurt
Austria	Rehazentrum Weißer Hof	Klosterneuburg
Austria	Unfallkrankenhaus Linz	Linz
Austria	Unfallkrankenhaus Salzburg	Salzburg
Austria	Universitätsklinik für Orthopädie und Traumatologie	Salzburg
Austria	Unfallkrankenhaus St. Pölten	St. Pölten
Austria	SMZ Ost, Donauspital Abteilung für Unfallchirurgie	Wien
Austria	Unfallkrankenhaus Lorenz Böhler	Wien
Austria	Unfallkrankenhaus Meidling	Wien
Austria	Universitätsklinik Wien, AKH	Wien

Sponsors (1)

Lead Sponsor	Collaborator
AUVA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade	the AIS grade ranges from AIS A to AIS D, whereby AIS A are complete lesions and AIS B-D represent incomplete lesions	day 0 to 6 month
Secondary	degree of spasticity	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	day 0 to 6 month
Secondary	Walking ability (yes/no)	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	day 0 to 6 month
Secondary	Urological function	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?	day 0 to 6 month
Secondary	Plantar reflex (left/right: yes/no)	The plantar reflex (also called Babinski Test) will be performed separately on each foot to assess if pathological reflexes are present.	day 0 to 6 month
Secondary	Independence in everyday life	of patients is assessed with the Spinal Cord Independence Measure (SCIM II)	day 0 to 6 month
Secondary	adverse events (AEs)	The number of study related adverse events (AEs) are measured according to NCI CTCAE, version 5.0.	day 0 to 21 days
Secondary	Nine-Hole Peg Test (NHPT) (if feasible)	An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5	day 0 to 6 month
Secondary	Grasp and Release Test (GRT)	An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5	day 0 to 6 month
Secondary	Pinch grip: yes/no	An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5	day 0 to 6 month
Secondary	Clenched grip: yes/no	An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5	day 0 to 6 month
Secondary	Pencil grip: yes/no	An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5	day 0 to 6 month
Secondary	Lumbrical grip: yes/no	An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5	day 0 to 6 month