NeuroAiD Safe Treatment Registry

Recruiting

• Conditions: Brain Injury; NeuroAiD Use

• Registration Number: NCT02536079
• Lead Sponsor: CHIMES Society

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 )
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

Trial Locations

Locations (2)

National Brain Center Hospital; 🇮🇩 Jakarta, Indonesia

University Kebangsaan Malaysia Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia