Neurorecovery program to improve breathing and arm function 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

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.

Why it matters

Who can join: the full rules

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 it's running

• Austin Health
  Heidelberg, Victoria, Australia Recruiting

Study contacts

• Principal investigator: David Berlowitz, PhD — University of Melbourne
• Study coordinator: Laura Stendell
• Email: laura.stendell@unimelb.edu.au
• Phone: (+61) 468 862 693

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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.