Spinal Cord Injury Neurorecovery Collaboration (SCINC)

University of Melbourne

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)

Study type: Interventional

Funder types: Other

Identifiers

NCT06871254

SCINC_MASTER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

RRULI: Appendix 1

Experimental group

Description:

In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention.

Treatment:

Other: Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)