Surgical procedure to improve outcomes after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether duroplasty, a surgical procedure that involves opening the dura and applying a patch to relieve pressure on the spinal cord, can improve outcomes for patients with severe spinal cord injuries. The study will compare the effects of duroplasty combined with bony decompression against bony decompression alone in adult patients with acute, severe cervical spinal cord injuries. The primary focus is to assess improvements in muscle strength at six months post-surgery, along with secondary outcomes related to functional health and quality of life. The trial aims to recruit 222 participants and is designed as a multicenter randomized controlled trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥16 years
2. Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)
3. Deemed to require and be suitable for surgery that includes laminectomy by local surgeon
4. Surgery within 72 hours of traumatic spinal cord injury
5. Able to provide informed consent or consultee declaration or proxy consent.

Exclusion Criteria:

1. Dural tear due to traumatic spinal cord injury
2. Life-limiting or rehabilitation-restricting co-morbidities
3. Thoracic or lumbar traumatic spinal cord injury
4. Other central nervous system disease

Where it's running

• Universität Klinik für Neurochirurgie
  Innsbruck, Austria Recruiting
• Kepler University Hospital
  Linz, Austria Recruiting
• University Hospital Salzburg
  Salzburg, Austria Recruiting
• St Polten University Hospital
  Sankt Pölten, Austria Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Marios C Papadopoulos — St George's, University of London, U.K.
• Study coordinator: Sophie Reynolds
• Email: discus@nds.ox.ac.uk
• Phone: 079 17100953

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury

  This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.

  Recruiting TryAbility LLC · Downers Grove, Illinois · NCT07922122

• NG004 for incomplete cervical spinal cord injury

  This trial tests NG004 versus placebo to see if it is safe and helps motor function and daily life in adults with acute incomplete cervical spinal cord injury.

  Recruiting at 7 sites Phase 1 NovaGo Therapeutics AG · Bayreuth and 9 other locations · NCT07840196

• Robot-assisted training for arm and leg movement after stroke or injury

  This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749625

• ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab

  This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.

  Recruiting Bangladesh Medical University · Dhaka, Dhaka Division · NCT07705906

• Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury

  This study tests whether using high-frequency sacral nerve stimulation together with bladder-directed ultrasound can reduce involuntary bladder contractions and improve bladder function in people with spinal cord injury.

  Recruiting Shengjing Hospital · Shenyang · NCT07704268

• Hybrid HIIT-FES cycling program for people with spinal cord injury

  This study tests a hybrid exercise program that combines functional electrical stimulation cycling with voluntary arm work to improve health in adults with spinal cord injury.

  Recruiting William Carey University · Hattiesburg, Mississippi · NCT07648173

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.