Neurorecovery program to improve breathing and arm function after spinal cord injury

Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol

This program will test whether combining short bouts of lowered oxygen (therapeutic intermittent hypoxia) with exercise training can help people with chronic cervical spinal cord injury (tetraplegia) regain breathing and upper‑limb function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Melbourne (other)
• Locations: 1 site (Heidelberg, Victoria)
• Trial ID: NCT06871254 on ClinicalTrials.gov

What this trial studies

SCINC is an adaptive Master Protocol that uses interim analyses and a Bayesian-optimized phase IIA design to decide which treatment combinations show enough promise to move forward. The first appendix (RRULI) tests therapeutic intermittent hypoxia combined with structured exercise training in people with chronic tetraplegia to look for gains in respiratory and upper-limb motor function, while monitoring feasibility and safety. The Master Protocol standardizes procedures, data collection, monitoring, follow-up, and safety across appendices, and allows new interventions to be added as separate appendices. Each appendix includes a process evaluation to track implementation and outcomes.

Who should consider this trial

Good fit: Adults over 18 with chronic (more than 1 year) cervical spinal cord injury (C2–T1) who have motor-incomplete tetraplegia in the upper limb, can breathe independently, and have a plan in place to manage autonomic dysreflexia are the ideal candidates.

Not a fit: People who are pregnant, medically unstable, have recent infections or pressure ulcers, poorly controlled diabetes, recent severe autonomic dysreflexia, or who have complete motor paralysis below the injury level are unlikely to benefit from this specific appendix.

Why it matters

Potential benefit: If successful, this approach could improve breathing and arm strength or control and thereby enhance independence and quality of life for people with chronic tetraplegia.

How similar studies have performed: Early-phase studies of therapeutic intermittent hypoxia have shown promising signals for respiratory and motor gains, but larger randomized trials are limited and the Master Protocol approach here is relatively novel.

Eligibility criteria

SCINC Inclusion Criteria:

\- Person with SCI

SCINC Exclusion Criteria:

\- Proven contraindication to intervention

RRULI: Appendix 1 (TIH + ET) study-specific inclusion criteria:

* Adults \> 18 years of age
* Able to independently ventilate
* Chronic SCI (\>1 years post-injury or impairment onset)
* Tetraplegia (C2-T1 level of injury)
* Evidence of motor incomplete paralysis in the upper limb below the neurological level of injury
* Have a documented management plan for their AD if it occurs.

RRULI: Appendix 1 (TIH + ET) study-specific exclusion criteria:

* Pregnancy
* Medical instability, including current or recent (within the previous 6 weeks) infection or inflammation
* Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions
* Poorly controlled diabetes
* An episode of AD in the previous 6 months that required medical intervention to resolve
* Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions.
* Currently taking part in another clinical trial
* Upper limb contracture

Where this trial is running

Heidelberg, Victoria

• Austin Health — Heidelberg, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: David Berlowitz, PhD — University of Melbourne
• Study coordinator: Laura Stendell

Conditions: Spinal Cord Injuries