## Protocol Section
### Identification Module
**NCT ID:** NCT02536079

**Acronym:** NeST

**Brief Title:** NeuroAiD Safe Treatment Registry

**Official Title:** NeuroAiD Safe Treatment Registry

#### Organization Study ID Info
**ID:** NeST2014
#### Organization
**Class:** OTHER
**Full Name:** CHIMES Society
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-06

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2015-08-31
**Type:** ESTIMATED
**Study First Submit Date:** 2015-08-26
**Study First Submit QC Date:** 2015-08-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Moleac Pte Ltd.

#### Lead Sponsor

**Class:** OTHER

**Name:** CHIMES Society

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Brain Injury

- NeuroAiD Use

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Months

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** NeuroAiD

**Other Names:**

- MLC601

- MLC901

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Compliance assessed as "since last visit, taking NeuroAiD..." never, 'rarely,' 'sometimes,' 'often,' 'always.'

**Measure:** Number of patients complying to prescribed dosage of NeuroAiD

**Time Frame:** 1, 2, 3 months

**Description:** 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)

**Measure:** Glasgow Outcome Scale Extended (GOS-E)

**Time Frame:** 1, 2, 3 months, additional visit

**Description:** 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

**Measure:** Rivermead Post-Concussion Symptom Questionnaire (RPQ)

**Time Frame:** 1, 2, 3 months, additional visit

**Description:** 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.

**Measure:** Modified Barthel Index

**Time Frame:** 1, 2, 3 months, additional visit

#### Primary Outcomes

**Description:** 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)

**Measure:** Number of patients experiencing adverse events

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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

**Measure:** Functional status based on modified Rankin Scale

**Time Frame:** 1, 2, 3 months

**Description:** 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 )

**Measure:** Neurological status based on Glasgow Coma Scale

**Time Frame:** 1, 2, 3 months

**Description:** 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

**Measure:** Neurological status based on National Institute of Health Stroke Scale

**Time Frame:** 1, 2, 3 months

**Description:** 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,

**Measure:** Cognitive status based on Short Orientation-Memory-Concentration Test

**Time Frame:** 1, 2, 3 months

**Description:** Orientation, Registration,Attention and Calculation,Recall, Language, Copying,

**Measure:** Cognitive status based on Mini-Mental State Examination (MMSE)

**Time Frame:** 3, 6,9, 12 months

**Description:** 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

**Measure:** Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)

**Time Frame:** 3, 6, 9, 12 months

**Description:** Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall

**Measure:** Cognitive status based on Montreal Cognitive Assessment (MoCA)

**Time Frame:** 3, 6, 9, 12 months

**Description:** 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

**Measure:** Functional outcome based on Bristol Activities of Daily Living (BADL)

**Time Frame:** 3, 6, 9, 12

### Eligibility Module

**Eligibility Criteria:** 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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** emily.lim@moleac.com

**Name:** Emily Lim

**Phone:** +6562113710

**Phone Ext:** 3184

**Role:** CONTACT

**Contact 2:**

**Email:** sylvain.durrleman@moleac.com

**Name:** Sylvain Durrleman, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jakarta

**Contacts:**

***Contact 1:***

- **Name:** Lyna Soertidewi

- **Role:** CONTACT

**Country:** Indonesia

**Facility:** National Brain Center Hospital

**Status:** RECRUITING

**Location 2:**

**City:** Kuala Lumpur

**Contacts:**

***Contact 1:***

- **Name:** Ramesh Kumar

- **Role:** CONTACT

**Country:** Malaysia

**Facility:** University Kebangsaan Malaysia Medical Centre

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Raffles Neuroscience Centre, Raffles Hospital, Singapore

**Name:** Narayanaswamy Venketasubramanian, FRCP

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia

**Name:** Ramesh Kumar, FRCS

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia

**Name:** Lyna Soertidewi, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 26567259

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

### Misc Info Module

- Version Holder: 2024-05-24
