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NCT Number: NCT06871254

Spinal Cord Injury Neurorecovery Collaboration

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location status: Recruiting

Location contact

Laura Stendell

CONTACT

[email protected]

(+61) 0468 862 693

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Other names: Therapeutic acute intermittent hypoxia (tAIH), Acute intermittent hypoxia (AIH)

Primary outcomes

  1. 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.

    Time frame: Baseline and 6-weeks.

    The single binary outcome includes the following components:

    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) B) No deterioration - No deterioration below baseline. C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant.

    D) Acceptability - Rate of participant adherence to intervention sessions. Please refer to the following primary outcomes for details of each of these components.

  2. 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)

    Time frame: Baseline and 6 week follow-up

    ARAT: Assesses grasp, grip, pinch and gross movement. A minimal clinically important difference of 5.7 points is accepted in SCI.

    GRIP: Grip strength will be measured according to a standardised procedure. A threshold of 5.0 kg will be used.

    MIP: Respiratory muscle strength will be measured according to standard procedures. A threshold of 10cmH20 will be used.

  3. B) No deterioration

    Time frame: Baseline and 6 week follow-up

    No deterioration (decline below baseline) that is equal or more than the predefined outcome-specific stated threshold, on ANY of the ARAT, GRIP and MIP.

  4. C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant.

    Time frame: Up to 6 weeks.

    Fewer than two AD events that fail to resolve with participants usual, community interventions.

  5. D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions..

    Time frame: Up to 6 weeks.

    Adherence with at least 70% of treatment sessions.

Secondary outcomes

  1. 9-hole Peg test

    Time frame: Baseline and 6-weeks.

    A test of upper limb dexterity and function. This test will be undertaken using the dominant hand.

  2. Pinch grip dynamometer

    Time frame: Baseline and 6-weeks.

    Pinch strength

  3. Penn Spasm Frequency Scale

    Time frame: Baseline and 6-weeks.

    Self-report measure of upper limb spasticity composed of 2-parts:

    • Spasm frequency: scale 0 (no spasm) - 4 (spasms occurring more than 10 times per hour).
    • Spasm severity: scale 1 (mild) - 3 (severe). A higher score indicates a worse outcome for both components of the scale.

  4. Capabilities of upper extremity questionnaire

    Time frame: Baseline and 6 weeks

    Questionnaire assessing upper limb function. Scored on a 7-point scale representing self-perceived difficulty:

    1= "totally limited, can't do at all" 7= "not at all limited" Minimum score = 32 Maximum score = 224 (higher score = greater function)

  5. Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study)

    Time frame: 1 day

    In the week prior to the intervention period, a home-based overnight polysomnography test will occur in the participants home to assess for OSA.

  6. Perceived work of breathing

    Time frame: Baseline and 6-weeks.

    Modified Borg dyspnoea scale. A scale from 0 (no difficulty breathing) - 10 (very, very severe) - where a higher score is a worse outcome.

  7. Respiratory function will assessed using spirometry.

    Time frame: Baseline and 6-weeks.

    Respiratory function measurement - physiological. Spirometry is a test of lung function and can measure how much air a person can force out of their lungs in 1 second (FEV1), and in total (forced vital capacity, FVC).

  8. Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)

    Time frame: Baseline and 6-weeks

    Respiratory muscle strength

  9. Peak cough flow (L/min)

    Time frame: Baseline and 6-weeks

    Cough effectiveness

  10. Minute Ventilation (Litres)

    Time frame: Baseline and 6-weeks.

    Ventilation response measurement - physiological.

  11. End of tidal breathing oxygen and carbon dioxide saturation.

    Time frame: Baseline and 6-weeks.

    Ventilation response measurement - physiological.

  12. Respiratory Rate measured in breaths per minute.

    Time frame: Baseline and 6-weeks.

    Ventilation response measurement - physiological.

  13. Tidal volume, measured in litres.

    Time frame: Baseline and 6-weeks.

    Ventilation response measurement - physiological measure.

  14. Ventilation response - assessing mouth pressure (measured in cmH20)

    Time frame: Baseline and 6-weeks.

    Ventilation response measure - physiological.

  15. Inspiratory time, measured in seconds (s).

    Time frame: Baseline and 6-weeks.

    Ventilation response measurement - physiological.

  16. Inspiratory and expiratory flow, measured in Litres per second (L/s).

    Time frame: Baseline and 6-weeks.

    Ventilation response measurement - physiological.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Stendell

CONTACT

[email protected]

(+61) 468 862 693

Nicole Sheers, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • Austin Health
  • Institute of Breathing and Sleep
  • Neuroscience Research Australia
  • The University of New South Wales
  • University of Florida
  • University of Sydney

Registry information

Official study title

Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol

Acronym: SCINC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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