Kumar Ramesh, Htwe Ohnmar, Baharudin Azmi, Ariffin Mohammad Hisam, Abdul Rhani Shaharuddin, Ibrahim Kamalnizat, Rustam Aishah, Gan Robert
Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Department of Orthopaedics and Traumatology, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
JMIR Res Protoc. 2016 Dec 5;5(4):e230. doi: 10.2196/resprot.6275.
Spinal cord injury (SCI) is a devastating condition with limited therapeutic options despite decades of research. Current treatment options include use of steroids, surgery, and rehabilitation. Nevertheless, many patients with SCI remain disabled. MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries and may have a potential role in improving recovery after SCI.
The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.
Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.
The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.
SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.
Clinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG).
脊髓损伤（SCI）是一种严重的疾病，尽管经过数十年的研究，治疗选择仍然有限。目前的治疗方法包括使用类固醇、手术和康复治疗。然而，许多脊髓损伤患者仍然残疾。MLC601（NeuroAiD）是一种天然产物的组合，已被证明是安全的，并且有助于脑损伤后的神经恢复，可能在改善脊髓损伤后的恢复方面具有潜在作用。
本研究的目的是评估NeuroAiD在研究环境中对脊髓损伤患者的安全性和有效性。
脊髓损伤——评估联合康复和NeuroAiD的耐受性及应用（SATURN）是一项针对中度至重度脊髓损伤患者的前瞻性队列研究，定义为美国脊髓损伤协会（ASIA）损伤量表（AIS）A和B级。除标准护理外，这些患者将接受为期6个月的开放标签NeuroAiD治疗，并随访24个月。将在基线以及第1、3、6、12、18和24个月前瞻性收集匿名数据，数据将包括人口统计学信息；主要诊断；以及通过脊髓独立测量、ASIA国际脊髓损伤神经分类标准和简短健康调查（SF-8）评估的神经和功能状态。此外，还将收集NeuroAiD治疗、依从性、伴随治疗以及任何副作用。研究人员将使用一个安全的在线系统进行数据录入。该研究已获得马来西亚国立大学医院伦理委员会的批准。
共同主要终点是6个月时的安全性、AIS分级和ASIA运动评分的改善情况。次要终点是其他时间点的AIS分级、ASIA运动评分和感觉评分、脊髓独立测量（SCIM）、SF-8健康调查以及依从性。
SATURN研究了NeuroAiD在脊髓损伤中可能发挥的作用，特别是考虑到其良好的安全性。我们在此描述了我们将用于这项前瞻性队列研究的方案和在线数据收集工具。选择中度至重度脊髓损伤患者，为研究NeuroAiD除标准康复治疗外对预后不良患者的作用提供了机会。研究结果将为开展更大规模的对照试验以改善脊髓损伤患者的长期预后的可行性提供重要信息。
Clinicaltrials.gov NCT02537899；https://clinicaltrials.gov/ct2/show/NCT02537899（由WebCite存档于http://www.webcitation.org/6m2pncVTG）。
