Brain Injury, NeuroAiD Use
Conditions
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.
Interventions
DRUGNeuroAiD
Sponsors
Moleac Pte Ltd.
CHIMES Society
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients experiencing adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Neurological status based on National Institute of Health Stroke Scale | 1, 2, 3 months | Quantify impairment caused by stroke 0- no stroke, 1-4 Minor stroke, 5-15 Moderate,16-20 Moderate to Severe stroke, 21-42 severe stroke |
| Cognitive status based on Mini-Mental State Examination (MMSE) | 3, 6,9, 12 months | Orientation, Registration,Attention and Calculation,Recall, Language, Copying, |
| Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog) | 3, 6, 9, 12 months | World recall, Naming of objects and fingers,Commands,Constructional Praxis,Ideational Praxis,Orientation, World Recognition,Language,Comprehension of spoken language,Word finding difficulty, Remembering test instructions |
| Cognitive status based on Montreal Cognitive Assessment (MoCA) | 3, 6, 9, 12 months | Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall |
| Functional outcome based on Bristol Activities of Daily Living (BADL) | 3, 6, 9, 12 | Preparing Food 3 Eating 3 Preparing Drink 3 Drinking 3 Dressing 3 Hygiene 3 Teeth 3 Bath/Shower 3 Toilet/Commode 3 Transfers 3 Mobility 3 Orientation - Time 3 Orientation - Space 3 Communication 3 Telephone 3 Housework/Gardening 3 Shopping 3 Finances 3 Games/Hobbies 3 Transport 3 |
| Functional status based on modified Rankin Scale | 1, 2, 3 months | 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Neurological status based on Glasgow Coma Scale | 1, 2, 3 months | to assess level of consciousness: eye opening, Eye opening 4, Eye Opening Response * Spontaneous--open with blinking at baseline 4 points * To verbal stimuli, command, speech 3 points * To pain only (not applied to face) 2 points * No response 1 point;Verbal Response * Oriented 5 points * Confused conversation, but able to answer questions 4 points * Inappropriate words 3 points * Incomprehensible speech 2 points * No response 1 point;Verbal Response * Oriented 5 points * Confused conversation, but able to answer questions 4 points * Inappropriate words 3 points * Incomprehensible speech 2 points * No response 1 point;Motor Response * Obeys commands for movement 6 points * Purposeful movement to painful stimulus 5 points * Withdraws in response to pain 4 points * Flexion in response to pain (decorticate posturing) 3 points * Extension response in response to pain (decerebrate rigidity ) |
| Cognitive status based on Short Orientation-Memory-Concentration Test | 1, 2, 3 months | test involves 6 items test -1.what year is it now?2.What month is it now?3.Repeat phrase, about what time is it ? (within one hour),Count backwards 20 to 1,Say months in reversw order,repeat phrase just given, |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post-Concussion Symptom Questionnaire (RPQ) | 1, 2, 3 months, additional visit | For Traumatic Brain Injury Cohort. This questionnaire is a simple, 10-item measure of outcome mainly used with patients with mild to moderate head injuries. This questionnaire explores the occurrence of 16 post-concussive symptoms such as headaches, fatigue, and restlessness |
| Modified Barthel Index | 1, 2, 3 months, additional visit | For Traumatic Brain Injury cohort. This scale assesses functional disability by quantifying patient performance in 10 activities of daily life (ADLs). This scale measures performance and patient independence with respect to self-care, sphincter management, transfers and locomotion. The score is calculated by summing the response value to each item. |
| Number of patients complying to prescribed dosage of NeuroAiD | 1, 2, 3 months | Compliance assessed as since last visit, taking NeuroAiD... never, 'rarely,' 'sometimes,' 'often,' 'always.' |
| Glasgow Outcome Scale Extended (GOS-E) | 1, 2, 3 months, additional visit | For Traumatic Brain injury cohort:This clinical scale is the most widely used outcome measure after TBI. The extended version is rated from 0 (dead) to 8 (full recovery) |
Countries
Indonesia, Malaysia
Contacts
Primary ContactEmily Lim
Backup ContactSylvain Durrleman, PhD
Outcome results
None listed