Acute Traumatic Spinal Cord InjuryNCT04474106
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
A study testing Shock waves and dummy head in people with Acute Traumatic Spinal Cord Injury, run by AUVA at 15 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Traumatic Spinal Cord Injury
- What is being tested?
- Shock waves and dummy head
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 15 sitesAustria
- Study dates
- 2 Jul 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iris Leister, MSc contact
15 sites in 1 country
Austria15 sites, 9 recruiting
- Active, not recruiting
Rehazentrum Bad Häring
Bad Häring, 6323
- Recruiting
Landeskarnkenhaus Feldkirch
Feldkirch, 6807
Rene El-Attal, Prim
- Recruiting
Unfallkrankenhaus Graz
Graz, 8020
Michael Plecko, Prim
- Active, not recruiting
Rehazentrum Tobelbad
Graz, 8144
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Richard Lindtner, Dr
Rene Schmid, Dr.
- Recruiting
Unfallkrankenhaus Klagenfurt
Klagenfurt, 9020
Rudolf Pranzl, Prim.
- Active, not recruiting
Rehazentrum Weißer Hof
Klosterneuburg, 3400
- Recruiting
Unfallkrankenhaus Linz
Linz, 4010
Klaus Katzensteiner, Prim.
- Recruiting
Unfallkrankenhaus Salzburg
Salzburg, 5010
Arnold Suda, Prim.
- Withdrawn
Universitätsklinik für Orthopädie und Traumatologie
Salzburg, 5020
- Withdrawn
Unfallkrankenhaus St. Pölten
Sankt Pölten, 3100
- Recruiting
Universitätsklinik Wien, AKH
Vienna, 1090
Stefan Hajdu, Prof.
- Recruiting
Unfallkrankenhaus Meidling
Vienna, 1120
Christian Fialka, Prim.
- Withdrawn
Unfallkrankenhaus Lorenz Böhler
Vienna, 1200
- Not yet recruiting
SMZ Ost, Donauspital Abteilung für Unfallchirurgie
Vienna, 1220
Medhi Mousavi, Prim
About this study
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
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.
Read more
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
- Being tested
- Shock waves, dummy head
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wavesDevice
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 headDevice
The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: dummy head |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0 to 6 month
Secondary outcomes (13)
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
Measured: day 0 to 6 month
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
Measured: day 0 to 6 month
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
Measured: day 0 to 6 month
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?
Measured: day 0 to 6 month
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.
Measured: day 0 to 6 month
Independence in everyday life
of patients is assessed with the Spinal Cord Independence Measure (SCIM II)
Measured: day 0 to 6 month
adverse events (AEs)
The number of study related adverse events (AEs) are measured according to NCI CTCAE, version 5.0.
Measured: day 0 to 21 days
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
Measured: day 0 to 6 month
Grasp and Release Test (GRT)
An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
Measured: day 0 to 6 month
Pinch grip: yes/no
An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
Measured: day 0 to 6 month
Clenched grip: yes/no
An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
Measured: day 0 to 6 month
Pencil grip: yes/no
An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
Measured: day 0 to 6 month
Lumbrical grip: yes/no
An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
Measured: day 0 to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start2 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Traumatic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm three-stage adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AUVA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Schaden, AUVA
- Investigators
- Wolfgang Schaden, Dr., Principal investigator, AUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474106
- Sponsor's protocol ID
- NEUROwave
- Status last verified
- Jan 2024
- First submitted
- 30 Jun 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nagele S, Zellmer B, Graber M, Winter-Polzl L, Engler C, Hirsch J, Schmidt S, Eder J, Lohmann R, Ioannou-Nikolaidou M, Heim V, Grimm M, Bonaros N, Gollmann-Tepekoylu C, Holfeld J, Nagele F. Current Preclinical and Clinical Evidence of Shock Wave Therapy for Spinal Cord Injury: A Systematic Review. Cells. 2026 Apr 13;15(8):687. doi: 10.3390/cells15080687.
PubMed 42041555Leister 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.
PubMed 35365190
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04474106
- Acronym / sponsor ID
- NEUROwave
- Conditions
- Acute Traumatic Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- AUVAUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm three-stage adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| ESWT | Experimental | Device: Shock wavesThe 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. |
| Control | Sham comparator | Device: dummy headIn the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock wavesThe 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. | Device | ESWT |
| dummy headThe shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves | Device | Control |
Primary outcome
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.
13 secondary outcomes
American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade
Time frame: day 0 to 6 month
degree of spasticity
Time frame: day 0 to 6 month
Walking ability (yes/no)
Time frame: day 0 to 6 month
Urological function
Time frame: day 0 to 6 month
Plantar reflex (left/right: yes/no)
Time frame: day 0 to 6 month
Independence in everyday life
Time frame: day 0 to 6 month
adverse events (AEs)
Time frame: day 0 to 21 days
Nine-Hole Peg Test (NHPT) (if feasible)
Time frame: day 0 to 6 month
Grasp and Release Test (GRT)
Time frame: day 0 to 6 month
Pinch grip: yes/no
Time frame: day 0 to 6 month
Clenched grip: yes/no
Time frame: day 0 to 6 month
Pencil grip: yes/no
Time frame: day 0 to 6 month
Lumbrical grip: yes/no
Time frame: day 0 to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 42041555Nagele S, Zellmer B, Graber M, Winter-Polzl L, Engler C, Hirsch J, Schmidt S, Eder J, Lohmann R, Ioannou-Nikolaidou M, Heim V, Grimm M, Bonaros N, Gollmann-Tepekoylu C, Holfeld J, Nagele F. Current Preclinical and Clinical Evidence of Shock Wave Therapy for Spinal Cord Injury: A Systematic Review. Cells. 2026 Apr 13;15(8):687. doi: 10.3390/cells15080687.
- Derived from this study: PubMed 35365190Leister 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iris Leister, MSc contact
Wolfgang Schaden, Dr. principal investigator
AUVA
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock waves and dummy head in people with Acute Traumatic Spinal Cord Injury, run by AUVA at 15 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Schaden, Dr (0043 5 9393 20170, wolfgang.schaden@auva.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline (time frame: day 0 to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474106, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.