Clinical trial NCT02536079: NeuroAiD Safe Treatment Registry
Official title: NeuroAiD Safe Treatment Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injury
NeuroAiD Use
Lead sponsor: CHIMES Society
Sponsor class: OTHER
Collaborators: name: Moleac Pte Ltd.
First posted: 2015-08-31
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Any age
* 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

Exclusion Criteria:

* Unwillingness to participate
* Contraindication to NeuroAiD

Primary outcomes:
measure: Number of patients experiencing adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Functional status based on modified Rankin Scale
timeFrame: 1, 2, 3 months
measure: Neurological status based on Glasgow Coma Scale
timeFrame: 1, 2, 3 months
measure: Neurological status based on National Institute of Health Stroke Scale
timeFrame: 1, 2, 3 months
measure: Cognitive status based on Short Orientation-Memory-Concentration Test
timeFrame: 1, 2, 3 months
measure: Cognitive status based on Mini-Mental State Examination (MMSE)
timeFrame: 3, 6,9, 12 months
measure: Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)
timeFrame: 3, 6, 9, 12 months
measure: Cognitive status based on Montreal Cognitive Assessment (MoCA)
timeFrame: 3, 6, 9, 12 months
measure: Functional outcome based on Bristol Activities of Daily Living (BADL)
timeFrame: 3, 6, 9, 12
Other outcomes:
measure: Number of patients complying to prescribed dosage of NeuroAiD
timeFrame: 1, 2, 3 months
measure: Glasgow Outcome Scale Extended (GOS-E)
timeFrame: 1, 2, 3 months, additional visit
measure: Rivermead Post-Concussion Symptom Questionnaire (RPQ)
timeFrame: 1, 2, 3 months, additional visit
measure: Modified Barthel Index
timeFrame: 1, 2, 3 months, additional visit
Locations:
city: Jakarta
country: Indonesia
facility: National Brain Center Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Kebangsaan Malaysia Medical Centre
Study officials:
affiliation: Raffles Neuroscience Centre, Raffles Hospital, Singapore
name: Narayanaswamy Venketasubramanian, FRCP
role: STUDY_CHAIR
affiliation: Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
name: Ramesh Kumar, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia
name: Lyna Soertidewi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venketasubramanian N, Kumar R, Soertidewi L, Abu Bakar A, Laik C, Gan R. The NeuroAiD Safe Treatment (NeST) Registry: a protocol. BMJ Open. 2015 Nov 13;5(11):e009866. doi: 10.1136/bmjopen-2015-009866.