NeuroAiD Safe Treatment Registry

Brain Injury Clinical Trial

— NeST  

Official title:

NeuroAiD Safe Treatment Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02536079
• Other study ID #: NeST2014
• Status: Recruiting
• Start date: June 2014
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: CHIMES Society
• Contact: Emily Lim
• Phone: +6562113710
• Email: emily.lim[@]moleac.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• NeuroAiD Use

Intervention

Drug:
• NeuroAiD

Locations

Country	Name	City	State
Indonesia	National Brain Center Hospital	Jakarta
Malaysia	University Kebangsaan Malaysia Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
CHIMES Society	Moleac Pte Ltd.

Countries where clinical trial is conducted

Indonesia,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients complying to prescribed dosage of NeuroAiD	Compliance assessed as "since last visit, taking NeuroAiD..." never, 'rarely,' 'sometimes,' 'often,' 'always.'	1, 2, 3 months
Other	Glasgow Outcome Scale Extended (GOS-E)	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)	1, 2, 3 months, additional visit
Other	Rivermead Post-Concussion Symptom Questionnaire (RPQ)	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	1, 2, 3 months, additional visit
Other	Modified Barthel Index	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.	1, 2, 3 months, additional visit
Primary	Number of patients experiencing adverse events	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)	3 months
Secondary	Functional status based on modified Rankin Scale	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	1, 2, 3 months
Secondary	Neurological status based on Glasgow Coma Scale	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 )	1, 2, 3 months
Secondary	Neurological status based on National Institute of Health Stroke Scale	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	1, 2, 3 months
Secondary	Cognitive status based on Short Orientation-Memory-Concentration Test	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,	1, 2, 3 months
Secondary	Cognitive status based on Mini-Mental State Examination (MMSE)	Orientation, Registration,Attention and Calculation,Recall, Language, Copying,	3, 6,9, 12 months
Secondary	Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)	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	3, 6, 9, 12 months
Secondary	Cognitive status based on Montreal Cognitive Assessment (MoCA)	Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall	3, 6, 9, 12 months
Secondary	Functional outcome based on Bristol Activities of Daily Living (BADL)	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	3, 6, 9, 12