Spinal Cord Injury Neurorecovery Collaboration

NCT06871254 | Recruiting DMC

• 1 other identifier: SCINC_MASTER
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• 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: 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.

  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.

  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.

  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.

  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.

  Up to 6 weeks.

Secondary Outcomes (16)

• 9-hole Peg test

  Baseline and 6-weeks.

• Pinch grip dynamometer

  Baseline and 6-weeks.

• Penn Spasm Frequency Scale

  Baseline and 6-weeks.

• Capabilities of upper extremity questionnaire

  Baseline and 6 weeks

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

  1 day

Study Arms (1)

RRULI: Appendix 1

EXPERIMENTAL

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

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

Interventions

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.

Also known as: Therapeutic acute intermittent hypoxia (tAIH), Acute intermittent hypoxia (AIH)

RRULI: Appendix 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Person with SCI

You may not qualify if:

• \- Proven contraindication to intervention
• 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.
• 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

Sponsors & Collaborators

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

Study Sites (1)

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Berlowitz, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Stendell

CONTACT

(+61) 468 862 693; laura.stendell@unimelb.edu.au

Nicole Sheers, PhD

CONTACT

nsheers@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Unending - beginning nine months following publication with no end date.
• Access Criteria: Proposals to access IPD must be directed to the study-specific principal investigator.

Locations

AU (1)