NeST: NeuroAiD Safe Treatment Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Functional status based on modified Rankin Scale [1, 2, 3 months]
0 No symptoms at all No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention 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 )
- 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 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,
- 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
Other Outcome Measures
- 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.'
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female
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Any age
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Taking, or has been prescribed NeuroAiD for any duration as judged by the physician and/or the participant
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Agrees to be included in the registry and allows retrieval and analysis of data in accordance with local requirements
Exclusion Criteria:
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Unwillingness to participate
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Contraindication to NeuroAiD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Brain Center Hospital | Jakarta | Indonesia | ||
| 2 | University Kebangsaan Malaysia Medical Centre | Kuala Lumpur | Malaysia |
Sponsors and Collaborators
- CHIMES Society
- Moleac Pte Ltd.
Investigators
- Study Chair: Narayanaswamy Venketasubramanian, FRCP, Raffles Neuroscience Centre, Raffles Hospital, Singapore
- Principal Investigator: Ramesh Kumar, FRCS, Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
- Principal Investigator: Lyna Soertidewi, MD, Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NeST2014