NCT06871254

Spinal Cord Injury Neurorecovery Collaboration

Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SCINC is an adaptive design Master protocol that seeks to determine if there is "sufficient promise" of beneficial effect of treatment combinations to enhance motor recovery in pre-specified strata of people with a spinal cord injury.

Detailed description

SCINC utilises an adaptive design with interim analyses to assess whether a given intervention is futile or shows a "signal of benefit" within an appendix-specific study. The SCINC Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. The study-specific Appendix is a Bayesian optimised phase IIA trial, operating under the overarching SCINC Master Protocol. The first study-specific appendix is: Restoration of Respiratory and Upper Limb function after cervical spinal cord Injury (RRULI): Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET). The RULLI: Appendix 1 (TIH + ET) aims to determine if ET plus TIH in people with chronic tetraplegia is a therapy with sufficient promise to test in a Phase IIb/III trial; considering feasibility, safety and efficacy. As new interventions are put forth, they will be added to the Master Protocol as a new Appendix. This Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. Each study-specific Appendix will have a process evaluation protocol.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)	TIH in combination with upper limb and respiratory ET. The intervention is predominantly home-based and will be delivered three times per week for six weeks.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-03-11
• Last updated: 2025-08-08

Locations

1 site across 1 country: Australia