Spinal Cord InjuriesSCINCNCT06871254
Spinal Cord Injury Neurorecovery Collaboration
A study testing Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET) in people with Spinal Cord Injuries, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nicole Sheers, PhD contact
Australia1 site, 1 recruiting
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Laura Stendell, (+61) 0468 862 693, laura.stendell@unimelb.edu.au
About this study
Official title: Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol
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.
Read the 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
- Being tested
- Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)Other
Also called Therapeutic acute intermittent hypoxia (tAIH), Acute intermittent hypoxia (AIH)
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.
| Study group | Role | What they receive |
|---|---|---|
| RRULI: Appendix 1 | Experimental | In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention. Receives: Other: Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The single binary outcome includes the following components:
- 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.
- Acceptability - Rate of participant adherence to intervention sessions. Please refer to the following primary outcomes for details of each of these components.
Measured: Baseline and 6-weeks.
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)
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.
Measured: Baseline and 6 week follow-up
B) No deterioration
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.
Measured: Baseline and 6 week follow-up
C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant.
Fewer than two AD events that fail to resolve with participants usual, community interventions.
Measured: Up to 6 weeks.
D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions..
Adherence with at least 70% of treatment sessions.
Measured: Up to 6 weeks.
Secondary outcomes (16)
9-hole Peg test
A test of upper limb dexterity and function. This test will be undertaken using the dominant hand.
Measured: Baseline and 6-weeks.
Pinch grip dynamometer
Pinch strength
Measured: Baseline and 6-weeks.
Penn Spasm Frequency Scale
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.
Measured: Baseline and 6-weeks.
Capabilities of upper extremity questionnaire
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)
Measured: Baseline and 6 weeks
Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study)
In the week prior to the intervention period, a home-based overnight polysomnography test will occur in the participants home to assess for OSA.
Measured: 1 day
Perceived work of breathing
Modified Borg dyspnoea scale. A scale from 0 (no difficulty breathing) - 10 (very, very severe) - where a higher score is a worse outcome.
Measured: Baseline and 6-weeks.
Respiratory function will assessed using spirometry.
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).
Measured: Baseline and 6-weeks.
Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)
Respiratory muscle strength
Measured: Baseline and 6-weeks
Peak cough flow (L/min)
Cough effectiveness
Measured: Baseline and 6-weeks
Minute Ventilation (Litres)
Ventilation response measurement - physiological.
Measured: Baseline and 6-weeks.
End of tidal breathing oxygen and carbon dioxide saturation.
Ventilation response measurement - physiological.
Measured: Baseline and 6-weeks.
Respiratory Rate measured in breaths per minute.
Ventilation response measurement - physiological.
Measured: Baseline and 6-weeks.
Tidal volume, measured in litres.
Ventilation response measurement - physiological measure.
Measured: Baseline and 6-weeks.
Ventilation response - assessing mouth pressure (measured in cmH20)
Ventilation response measure - physiological.
Measured: Baseline and 6-weeks.
Inspiratory time, measured in seconds (s).
Ventilation response measurement - physiological.
Measured: Baseline and 6-weeks.
Inspiratory and expiratory flow, measured in Litres per second (L/s).
Ventilation response measurement - physiological.
Measured: Baseline and 6-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Breathing and Sleep, Austin Health, Neuroscience Research Australia, The University of New South Wales, University of Sydney, University of Florida
- Responsible party
- Sponsor
- Investigators
- David Berlowitz, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871254
- Sponsor's protocol ID
- SCINC_MASTER
- Acronym
- SCINC
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant level data will be made available for research purposes upon approval of written requests at completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol
- ClinicalTrials.gov ID
- NCT06871254
- Acronym / sponsor ID
- SCINC / SCINC_MASTER
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Institute of Breathing and Sleep, Austin Health, Neuroscience Research Australia, The University of New South Wales, University of Sydney, University of Florida
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.
| Arm | Type | Receives |
|---|---|---|
| RRULI: Appendix 1 | Experimental | Other: Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)Also: Therapeutic acute intermittent hypoxia (tAIH), Acute intermittent hypoxia (AIH)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 | RRULI: Appendix 1 |
Primary outcome
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.
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.
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.
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.
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.
16 secondary outcomes
9-hole Peg test
Time frame: Baseline and 6-weeks.
Pinch grip dynamometer
Time frame: Baseline and 6-weeks.
Penn Spasm Frequency Scale
Time frame: Baseline and 6-weeks.
Capabilities of upper extremity questionnaire
Time frame: Baseline and 6 weeks
Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study)
Time frame: 1 day
Perceived work of breathing
Time frame: Baseline and 6-weeks.
Respiratory function will assessed using spirometry.
Time frame: Baseline and 6-weeks.
Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)
Time frame: Baseline and 6-weeks
Peak cough flow (L/min)
Time frame: Baseline and 6-weeks
Minute Ventilation (Litres)
Time frame: Baseline and 6-weeks.
End of tidal breathing oxygen and carbon dioxide saturation.
Time frame: Baseline and 6-weeks.
Respiratory Rate measured in breaths per minute.
Time frame: Baseline and 6-weeks.
Tidal volume, measured in litres.
Time frame: Baseline and 6-weeks.
Ventilation response - assessing mouth pressure (measured in cmH20)
Time frame: Baseline and 6-weeks.
Inspiratory time, measured in seconds (s).
Time frame: Baseline and 6-weeks.
Inspiratory and expiratory flow, measured in Litres per second (L/s).
Time frame: Baseline and 6-weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified participant level data will be made available for research purposes upon approval of written requests at completion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Sheers, PhD contact
David Berlowitz, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET) in people with Spinal Cord Injuries, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Stendell ((+61) 468 862 693, laura.stendell@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline and 6-weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.