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ClinicalTrials.gov Identifier: NCT02536079
Recruitment Status : Unknown
Verified February 2018 by CHIMES Society. Recruitment status was: Recruiting
The NeST registry is a pro-active industry-academic collaboration to assess the use and safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy data entry and retrieval of clinical information.
Condition or disease
Brain InjuryNeuroAiD Use
The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional, and cognitive state, compliance, concomitant medications and side effects if any, among patients on NeuroAiD. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialization of NeuroAiD) and during subsequent visits. The follow up visits are timed with clinical appointments. Anonymized data will be extracted and collectively analyzed. Initial target sample size for the registry is 2000.
Number of patients experiencing adverse events [ Time Frame: 3 months ]
Adverse events categorized according to individual events, organ system, severity (mild, moderate, severe), and relatedness (based on WHO-World Health Organization - Uppsala Monitoring System as 'possibly' 'probably' or 'definitely' related)
Secondary Outcome Measures :
Functional status based on modified Rankin Scale [ Time Frame: 1, 2, 3 months ]
Neurological status based on Glasgow Coma Scale [ Time Frame: 1, 2, 3 months ]
Neurological status based on National Institute of Health Stroke Scale [ Time Frame: 1, 2, 3 months ]
Cognitive status based on Short Orientation-Memory-Concentration Test [ Time Frame: 1, 2, 3 months ]
Other Outcome Measures:
Number of patients complying to prescribed dosage of NeuroAiD [ Time Frame: 1, 2, 3 months ]
Compliance assessed as "since last visit, taking NeuroAiD..." never, 'rarely,' 'sometimes,' 'often,' 'always.'
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The NeST Registry is a product-specific and safety outcome registry that includes patients who are taking NeuroAiD. Participation is entirely voluntary and an agreement will be obtained before inclusion. The decision on the use of NeuroAiD should be made following a discussion between participant and physician and only then will the option of participation in the registry be considered.
Male or female
Taking, or has been prescribed NeuroAiD for any duration as judged by the physician and/or the participant
Agrees to be included in the registry and allows retrieval and analysis of data in accordance with local requirements