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

AUVA

Status: Enrolling

Conditions: Acute Traumatic Spinal Cord Injury

Treatments: Device: dummy head; Device: Shock waves

Study type: Interventional

Funder types: Other

Identifiers

NCT04474106

NEUROwave

Details and patient eligibility

About

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.

Enrollment: 246 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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246 participants in 2 patient groups

ESWT

Experimental group

Description:

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.

Treatment:

Device: Shock waves

Control

Sham Comparator group

Description:

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

Treatment:

Device: dummy head