Spinal cord injury - assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study - primary results of an exploratory study.

OBJECTIVE: MLC601/MLC901 has demonstrated neuroprotective and neuroregenerative properties that enhance neurological recovery in stroke and traumatic brain injury. We aimed to evaluate its safety and potential efficacy in patients with severe spinal cord injury. METHODS: Patients with American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B were included in an open-label cohort study. Each received a course of MLC601/MLC901 for 6 months in addition to standard care and rehabilitation. Key endpoints were safety, AIS grade and motor scores at month 6 (M6). RESULTS: Among 30 patients included (mean age 42.2 ± 17.6 years, 24 men), 20 patients had AIS A while 10 patients had AIS B at baseline. Ten patients experienced 14 adverse events including one serious adverse event and six deaths, none were considered treatment-related. AIS improved in 25% of AIS A and 50% of AIS B. Improvement in ASIA motor score was seen most with cervical injury (median change from baseline 26.5, IQR: 6-55). These findings appear to be better than reported rates of spontaneous recovery for SCI AIS A and B. CONCLUSION: MLC601/MLC901 is safe and may have a role in the treatment of patients with SCI. A controlled trial is justified.

Cross-cultural Adaptation and Validity of the Patient Rated Michigan Hand Outcome Questionnaire in Bahasa Melayu for Malaysian Patients.

Background: The Michigan Hand Outcomes Questionnaire (MHQ) was designed in 1998 by Chung and colleagues at the University of Michigan in 1998. It is a hand-specific patient-rated outcome (PRO) instrument used to measure patients' outcome with conditions of, or injury to, the hand and/or wrist. This study is aimed at translating and cross-culturally adapting the MHQ into Bahasa Melayu (BM), examining the validity and reliability of the MHQ-BM version for our local population to be used as a patient-rated outcome measurement in Malaysian patients with hand injuries. Methods: This study was performed in two phases. Phase 1 involved the translation of the MHQ into BM using Beaton Protocol. In Phase 2, we administered the final version of the MHQ-BM in patients with hand and/or wrist injuries to test its stability (n = 50) and validity (n = 185). Results: The MHQ-BM showed good content and face validity. Cronbach α totalled 0.821 for the MHQ-BM. The Intra-class Correlation Coefficient (ICC) of the test-retest reliability for the six domains ranged from 0.960 to 0.984 with excellent correlation (ICC = 0.984) for the total score. The BM version of MHQ-BM showed excellent test-retest reliability. Conclusions: The MHQ-BM is well-translated and culturally well-adapted to maintain the reliability and content validity of the instrument (MHQ) at a conceptual level across Malaysia. We found the application and evaluation of the instrument to be feasible and understandable among patients with hand and/or wrist injuries in Malaysia.