Effects of N-Pep-12 dietary supplementation on neurorecovery after ischemic stroke.

BACKGROUND: The aim of the study was to evaluate the effects of N-Pep-12 dietary supplementation on neurorecovery of middle-aged and older adults with cognitive impairment after ischemic stroke, using neuropsychological outcome scales. METHODS: This was a pilot randomized-controlled, phase IV, academic clinical trial that aimed to assess the effect and the safety of a single daily dose of oral 90 mg of N-Pep-12 for 90 days in supporting neurorecovery, as compared with a control group, performed on middle-aged and older adults after supratentorial ischemic stroke. RESULTS: Study group differences in baseline changes at day 90 for Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect) were statistically significant (Mann-Whitney U test). For MoCA at day 90, a borderline 'intermediate effect' in favour of N-PEP-12 was observed (dCohen = 0.491, η2 = 0.057, OR = 2.436, p = 0.010). HADS Anxiety and Color Trails 1 at day 90 registered a 'small-to-intermediate' effect in favour of N-PEP-12 (dCohen = 0.424, η2 = 0.043, OR = 2.157, p = 0.026; dCohen = 0.481, η2 = 0.055, OR = 2.3927, p = 0.013, respectively). For symbol search errors, an 'intermediate' effect in favour of the control group was observed (dCohen = 0.501, η2 = 0.059, OR = 2.4811, p = 0.007). CONCLUSION: This exploratory clinical trial indicates a signal for the benefit of dietary supplementation with N-Pep-12 for the enhancement of neurorecovery after supratentorial ischemic stroke.

Preliminary evaluation of a measure for reliable assessment of need for constant visual observation in adults with traumatic brain injury.

PRIMARY OBJECTIVE: To develop and provide initial validation of a measure for accurately determining the need for Constant Visual Observation (CVO) in patients with traumatic brain injury (TBI) admitted to inpatient rehabilitation. RESEARCH DESIGN: Rating scale development and evaluation through Rasch analysis and assessment of concurrent validity. METHODS AND PROCEDURES: One hundred and thirty-four individuals with moderate-severe TBI were studied in seven inpatient brain rehabilitation units associated with the National Institute for Disability, Independent Living and Rehabilitation Research (NIDILRR) TBI Model System. Participants were rated on the preliminary version of the CVO Needs Assessment scale (CVONA) and, by independent raters, on the Levels of Risk (LoR) and Supervision Rating Scale (SRS) at four time points during inpatient rehabilitation: admission, Days 2-3, Days 5-6 and Days 8-9. OUTCOMES AND RESULTS: After pruning misfitting items, the CVONA showed satisfactory internal consistency (Person Reliability = 0.85-0.88) across time points. With reference to the LoR and SRS, low false negative rates (sensitivity > 90%) were associated with moderate-to-high false positive rates (29-56%). CONCLUSIONS: The CVONA may be a useful objective metric to complement clinical judgement regarding the need for CVO; however, further prospective study is desirable to further assess its utility in identifying at-risk patients, reducing adverse events and decreasing CVO costs.