Spinal Cord Injury Neurorecovery Collaboration

NCT ID: NCT06871254

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

SCINC Master protocol:

\- Where multiple simultaneous appendices/interventions are evaluated the intent is to keep the independent assessor blinded to the intervention allocation.

RRULI: Appendix 1:

\- The outcome assessor will be independent of the providers of therapy.

Study Groups

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RRULI: Appendix 1

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Therapeutic acute intermittent hypoxia (tAIH) Acute intermittent hypoxia (AIH)

Eligibility Criteria

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Inclusion Criteria

\- Person with SCI


* 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.

Exclusion Criteria

\- Proven contraindication to intervention


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Breathing and Sleep

UNKNOWN

Sponsor Role collaborator

Austin Health

OTHER_GOV

Sponsor Role collaborator

Neuroscience Research Australia

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Berlowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

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Austin Health

Heidelberg, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Laura Stendell

Role: CONTACT

(+61) 468 862 693

Nicole Sheers, PhD

Role: CONTACT

Facility Contacts

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Laura Stendell

Role: primary

(+61) 0468 862 693

Other Identifiers

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SCINC_MASTER

Identifier Type: -

Identifier Source: org_study_id

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