Clinical trial NCT06871254: Spinal Cord Injury Neurorecovery Collaboration
Official title: Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Institute of Breathing and Sleep
name: Austin Health
name: Neuroscience Research Australia
name: The University of New South Wales
name: University of Sydney
First posted: 2025-03-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: At an individual participant level, the Phase IIA study has a single, binary, composite primary outcome to determine if there is a 'signal of benefit', measuring effectiveness, no deterioration, safety and acceptability.
timeFrame: Baseline and 6-weeks.
measure: A) Effectiveness: Increase above baseline that is equal or more than the predefined outcome-specific stated thresholds, on at least ONE of the: Action Reach Arm Test (ARAT), Handheld dynamometer (GRIP) Maximal inspiratory pressure (MIP)
timeFrame: Baseline and 6 week follow-up
measure: B) No deterioration
timeFrame: Baseline and 6 week follow-up
measure: C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant.
timeFrame: Up to 6 weeks.
measure: D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions..
timeFrame: Up to 6 weeks.
Secondary outcomes:
measure: 9-hole Peg test
timeFrame: Baseline and 6-weeks.
measure: Pinch grip dynamometer
timeFrame: Baseline and 6-weeks.
measure: Penn Spasm Frequency Scale
timeFrame: Baseline and 6-weeks.
measure: Capabilities of upper extremity questionnaire
timeFrame: Baseline and 6 weeks
measure: Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study)
timeFrame: 1 day
measure: Perceived work of breathing
timeFrame: Baseline and 6-weeks.
measure: Respiratory function will assessed using spirometry.
timeFrame: Baseline and 6-weeks.
measure: Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)
timeFrame: Baseline and 6-weeks
measure: Peak cough flow (L/min)
timeFrame: Baseline and 6-weeks
measure: Minute Ventilation (Litres)
timeFrame: Baseline and 6-weeks.
measure: End of tidal breathing oxygen and carbon dioxide saturation.
timeFrame: Baseline and 6-weeks.
measure: Respiratory Rate measured in breaths per minute.
timeFrame: Baseline and 6-weeks.
measure: Tidal volume, measured in litres.
timeFrame: Baseline and 6-weeks.
measure: Ventilation response - assessing mouth pressure (measured in cmH20)
timeFrame: Baseline and 6-weeks.
measure: Inspiratory time, measured in seconds (s).
timeFrame: Baseline and 6-weeks.
measure: Inspiratory and expiratory flow, measured in Litres per second (L/s).
timeFrame: Baseline and 6-weeks.
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: David Berlowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: