Spinal Cord Injury Neurorecovery Collaboration

Официальное название

Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: 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) [Срок оценки: Baseline and 6 week follow-up]
• B) No deterioration [Срок оценки: Baseline and 6 week follow-up]
• C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant. [Срок оценки: Up to 6 weeks.]
• D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions.. [Срок оценки: Up to 6 weeks.]

Вторичные конечные точки (12)

• 9-hole Peg test [Срок оценки: Baseline and 6-weeks.]
• Pinch grip dynamometer [Срок оценки: Baseline and 6-weeks.]
• Penn Spasm Frequency Scale [Срок оценки: Baseline and 6-weeks.]
• Capabilities of upper extremity questionnaire [Срок оценки: Baseline and 6 weeks]
• Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study) [Срок оценки: 1 day]
• Perceived work of breathing [Срок оценки: Baseline and 6-weeks.]
• Respiratory function will assessed using spirometry. [Срок оценки: Baseline and 6-weeks.]
• Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP) [Срок оценки: Baseline and 6-weeks]
• Peak cough flow (L/min) [Срок оценки: Baseline and 6-weeks]
• Minute Ventilation (Litres) [Срок оценки: Baseline and 6-weeks.]
• End of tidal breathing oxygen and carbon dioxide saturation. [Срок оценки: Baseline and 6-weeks.]
• Respiratory Rate measured in breaths per minute. [Срок оценки: Baseline and 6-weeks.]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Austin Health — Heidelberg

Идентификаторы

NCT: NCT06871254 · SCINC_MASTER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗