NeuroAiD Safe Treatment Registry (NeST)

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Injury; NeuroAiD Use
• Intervention / Treatment: Drug: NeuroAiD

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Emily Lim; Phone Number: 3184 +6562113710; Email: emily.lim@moleac.com
• Study Contact Backup: Name: Sylvain Durrleman, PhD; Email: sylvain.durrleman@moleac.com

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Recruiting
    • National Brain Center Hospital
    • Contact: Lyna Soertidewi
• Malaysia
  • Kuala Lumpur, Malaysia
    • Recruiting
    • University Kebangsaan Malaysia Medical Centre
    • Contact: Ramesh Kumar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Cognitive status based on Mini-Mental State Examination (MMSE)	Orientation, Registration,Attention and Calculation,Recall, Language, Copying,	3, 6,9, 12 months
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
Cognitive status based on Montreal Cognitive Assessment (MoCA)	Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall	3, 6, 9, 12 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: CHIMES Society
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: NeST2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No