Brain InjuryNeSTNCT02536079
NeuroAiD Safe Treatment Registry
An observational study of Brain Injury and NeuroAiD Use, run by CHIMES Society at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injury, NeuroAiD Use
- What is being tested?
- NeuroAiD
- How many people
- 2,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2014to Dec 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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
Who cannot join
- Unwillingness to participate
- Contraindication to NeuroAiD
Trial locations and contacts
2 sites in 2 countries.
Sylvain Durrleman, PhD contact
2 sites in 2 countries
Indonesia1 site, 1 recruiting
- Recruiting
National Brain Center Hospital
Jakarta
Lyna Soertidewi
Malaysia1 site, 1 recruiting
- Recruiting
University Kebangsaan Malaysia Medical Centre
Kuala Lumpur
Ramesh Kumar
About this study
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.
Read the 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
- Brain Injury, NeuroAiD Use
- Being tested
- NeuroAiD
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroAiDDrug
Also called MLC601, MLC901
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (8)
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
Measured: 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 )
Measured: 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
Measured: 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,
Measured: 1, 2, 3 months
Cognitive status based on Mini-Mental State Examination (MMSE)
Orientation, Registration,Attention and Calculation,Recall, Language, Copying,
Measured: 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
Measured: 3, 6, 9, 12 months
Cognitive status based on Montreal Cognitive Assessment (MoCA)
Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall
Measured: 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
Measured: 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- CHIMES Society
- Sponsor type
- University, hospital or other
- Collaborators
- Moleac Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Narayanaswamy Venketasubramanian, FRCP, Study chair, Raffles Neuroscience Centre, Raffles Hospital, SingaporeRamesh Kumar, FRCS, Principal investigator, Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, MalaysiaLyna Soertidewi, MD, Principal investigator, Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536079
- Sponsor's protocol ID
- NeST2014
- Acronym
- NeST
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2015
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26567259
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroAiD Safe Treatment Registry
- ClinicalTrials.gov ID
- NCT02536079
- Acronym / sponsor ID
- NeST / NeST2014
- Conditions
- Brain Injury, NeuroAiD Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- CHIMES SocietyUniversity, hospital or other
- Collaborators
- Moleac Pte Ltd.
- Study start
- Jun 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwillingness to participate
- Contraindication to NeuroAiD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroAiDAlso: MLC601, MLC901 | Drug | – |
Primary outcome
Number of patients experiencing adverse events
Time frame: 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)
8 secondary outcomes
Functional status based on modified Rankin Scale
Time frame: 1, 2, 3 months
Neurological status based on Glasgow Coma Scale
Time frame: 1, 2, 3 months
Neurological status based on National Institute of Health Stroke Scale
Time frame: 1, 2, 3 months
Cognitive status based on Short Orientation-Memory-Concentration Test
Time frame: 1, 2, 3 months
Cognitive status based on Mini-Mental State Examination (MMSE)
Time frame: 3, 6,9, 12 months
Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)
Time frame: 3, 6, 9, 12 months
Cognitive status based on Montreal Cognitive Assessment (MoCA)
Time frame: 3, 6, 9, 12 months
Functional outcome based on Bristol Activities of Daily Living (BADL)
Time frame: 3, 6, 9, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 26567259Venketasubramanian 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.
Related trials for Brain Injury
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
RecruitingObservational study
the Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury
Traumatic Brain Injury
Enrolling by invitation
BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Traumatic Brain Injury
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Durrleman, PhD contact
Narayanaswamy Venketasubramanian, FRCP study chair
Raffles Neuroscience Centre, Raffles Hospital, Singapore
Ramesh Kumar, FRCS principal investigator
Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
Lyna Soertidewi, MD principal investigator
Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and NeuroAiD Use, run by CHIMES Society at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Lim (+6562113710 ext. 3184, emily.lim@moleac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing adverse events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02536079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.