Stroke, IschemicBHSNCT03592563
CUHK Brain Health Longitudinal Study
An observational study of Stroke, Ischemic and Stroke Syndrome, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The goal of this study is to develop a large longitudinal cohort of individuals diagnosed with or at high risk for brain diseases (both neurological and psychiatric in nature), in order to identify risk factors that contribute to neurological and psychiatric diseases over time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Stroke Syndrome, Stroke
- What is being tested?
- Neuro-QoL questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jul 2019to 31 Dec 2048
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Chinese ONLY 2. Hong Kong Resident
Who may be able to join
- Adult ≥ 18 years of age
- Fulfilling criteria for membership in one of these three groups:
- Red group: established diagnosis of one or more neurological and/or psychiatric conditions
- Yellow group: high-risk to develop one or more neurological and/or psychiatric conditions
- family history (first degree relative) one or more neurological and/or psychiatric conditions
- examination, imaging or laboratory findings consistent with pre-symptomatic stages of one or more neurological and/or psychiatric disorders
Show all 9Show fewer
- Green group: not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of brain health
- Subject provides informed consent by signing and dating the written informed consent form
- Subject is willing to answer health questionnaires and be followed longitudinally
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Thomas Wai Hong LEUNG, FRCP, 852-35053593, drtleung@cuhk.edu.hk
Anki MIU, MSc, 852-28902002, ankimiu@cuhk.edu.hk
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Thomas Wai Hong LEUNG, FRCP, 852-35053593, drtleung@cuhk.edu.hk
About this study
The goal of this study is to develop a large longitudinal cohort of individuals diagnosed with or at high risk for brain diseases (both neurological and psychiatric in nature), in order to identify risk factors that contribute to neurological and psychiatric diseases over time. The investigators seek to capture relevant information from medical records, electronically administered questionnaires and follow up phone-based interviews. The investigators expect to eventually have sufficient power from our dataset to examine risk factors for a variety of brain disorders, both individually and in aggregate. Our ultimate goal is to offer scientifically validated ways to preserve and promote brain health by working with our patients' needs and tracking their progress over time.
Read the detailed description
For those interested participants, our services coordinator, co-investigator or principal investigator will interview and explain the study in detail and obtain your consent. After signed the consent, the participant should complete the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire first, either on-site at CUHK Brain Health Centre located at Tsim Sha Tsui in Hong Kong, PWH or community centre. The questions in the questionnaire focus on the following: ability to participate in social roles, emotional and behavioral dyscontrol, fatigue, lower extremity function, stigma, upper extremity function, positive affect and well-being, satisfaction with social roles, cognitive function, anxiety and depression. These questions enable us to get a full picture of the participant's health. Participants in Green and yellow groups will receive this standard battery of questions. However, participants in Red group may receive an additional subset of questions based on their clinical diagnosis. Once again, all subjects are asked to complete this questionnaire for clinical evaluation purposes, regardless of whether or not they decide to participate in this study.
When the participant is willing to join the study, an evaluation would be scheduled. At that visit, our physician and/or study coordinator will review the participant's medical history, current concerns, and responses to the questionnaires. Diagnostic and therapeutic recommendations may be offered, as warranted. The investigator or physician will determine whether a follow-up clinic visit is warranted. Depending on the physician's recommendations, the participant will either participate in a research phone call in approximately 6 months, or will be scheduled for in person research follow up. In addition to the phone call or clinic visit, and will also receive an identical questionnaire to the first one by e-mail, by phone, or in person. Follow-up over time will continue (either in-person or over the phone) using the same questionnaires at approximately 6-month intervals. During follow-up, participant will be screened for new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
The proposed study does not involve formulating new diagnoses or directly offering treatment for neurological and/or psychiatric conditions. All patients admitted to PWH or other medical institutes will be treated according to the standard care at the corresponding institution, regardless of their decision to participate in this repository. Should results from this study lead to discovery of one or more factors associated with development of brain disease, the principal investigators, co-investigators, or study coordinator in the CUHK Brain Health Centre will inform, counsel and offer diagnostic and/or therapeutic recommendations to participants accordingly. The participants may be referred to relevant departments for follow-up clinical visits and may also be invited to participate in sister research projects at PWH/CUHK that have obtained ethics approval; if the participants are interested in any sister projects, they may be offered tests as the study procedures of these projects, including but not limited to blood tests, genetic tests, retinal imaging and brain imaging exams.
Our study aims to follow longitudinally individuals with or at risk for neurological and psychiatric disease, regardless of gender or sexual orientation. The investigators focus on enrolling adults as the vast majority of the neurological and psychiatric conditions of interest are diagnosed well into adulthood; indeed, most are age-related and particularly frequent among individuals in the fifth decade of life and beyond. Our study uniquely welcomes even individuals who are healthy from a brain standpoint, and offers them an opportunity to increase our scientific understanding of the early transition from normal to pathological brain functioning. As a result, the entire population as a whole stand to potentially benefit from the outcomes of the proposed research.
- Conditions
- Stroke, Ischemic, Stroke Syndrome, Stroke, Stroke, Acute, Dementia, Brain Ischemia
- Being tested
- Neuro-QoL questionnaire
- Keywords
- stroke, dementia, Alzheimer disease, Health Brain, Health knowledge
- Medical subject headings
- Ischemic Stroke, Stroke, Dementia, Brain Ischemia, Brain Diseases, Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-QoL questionnaireBehavioural
Follow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals. During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
| Study group | Role | What they receive |
|---|---|---|
| Red group | Those participants who had established diagnosis of one or more neurological and/or psychiatric conditions
Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire plus an additional subset of questions based on their clinical diagnosis should be done. Receives: Behavioral: Neuro-QoL questionnaire | |
| Yellow group | Those participants who are high-risk to develop one or more neurological and/or psychiatric conditions, for example:
1. family history (first degree relative) one or more neurological and/or psychiatric conditions;
2. examination, imaging or laboratory findings consistent with pre-symptomatic stages of one or more neurological and/or psychiatric disorders.
Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire should be done. Receives: Behavioral: Neuro-QoL questionnaire | |
| Green group | Those participants who are not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of their brain health.
Baseline: The participants' medical history would be recorded and Neuro-QoL questionnaire should be done. Receives: Behavioral: Neuro-QoL questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors contributing to neurological and psychiatric diseases
The participants' electronic medical records and questionnaires done (either symptomatic or asymptomatic) would be compared with their follow-up electronic medical records/phone follow-up interview and questionnaires done over time.
Measured: December, 2038
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jul 2019
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Wai Hong Thomas, Chinese University of Hong Kong
- Investigators
- Thomas Wai Hong LEUNG, FRCP, Principal investigator, Division of Neurology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592563
- Sponsor's protocol ID
- Crec No. 2018.148
- Acronym
- BHS
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2018
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and health information may be sent out to our research collaborators at Massachusetts General Hospital and Harvard Medical School, where there is a sister institute for brain health for additional analysis.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CUHK Brain Health Longitudinal Study
- ClinicalTrials.gov ID
- NCT03592563
- Acronym / sponsor ID
- BHS / Crec No. 2018.148
- Conditions
- Stroke, Ischemic, Stroke Syndrome, Stroke, Stroke, Acute, Dementia, Brain Ischemia
- Keywords
- stroke, dementia, Alzheimer disease, Health Brain, Health knowledge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2048 (estimated)
- First posted
- 19 Jul 2018 (actual)
- 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 goal of this study is to develop a large longitudinal cohort of individuals diagnosed with or at high risk for brain diseases (both neurological and psychiatric in nature), in order to identify risk factors that contribute to neurological and psychiatric diseases over time. The investigators seek to capture relevant information from medical records, electronically administered questionnaires and follow up phone-based interviews. The investigators expect to eventually have sufficient power from our dataset to examine risk factors for a variety of brain disorders, both individually and in aggregate. Our ultimate goal is to offer scientifically validated ways to preserve and promote brain health by working with our patients' needs and tracking their progress over time.
Detailed description
For those interested participants, our services coordinator, co-investigator or principal investigator will interview and explain the study in detail and obtain your consent. After signed the consent, the participant should complete the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire first, either on-site at CUHK Brain Health Centre located at Tsim Sha Tsui in Hong Kong, PWH or community centre. The questions in the questionnaire focus on the following: ability to participate in social roles, emotional and behavioral dyscontrol, fatigue, lower extremity function, stigma, upper extremity function, positive affect and well-being, satisfaction with social roles, cognitive function, anxiety and depression. These questions enable us to get a full picture of the participant's health. Participants in Green and yellow groups will receive this standard battery of questions. However, participants in Red group may receive an additional subset of questions based on their clinical diagnosis. Once again, all subjects are asked to complete this questionnaire for clinical evaluation purposes, regardless of whether or not they decide to participate in this study.
When the participant is willing to join the study, an evaluation would be scheduled. At that visit, our physician and/or study coordinator will review the participant's medical history, current concerns, and responses to the questionnaires. Diagnostic and therapeutic recommendations may be offered, as warranted. The investigator or physician will determine whether a follow-up clinic visit is warranted. Depending on the physician's recommendations, the participant will either participate in a research phone call in approximately 6 months, or will be scheduled for in person research follow up. In addition to the phone call or clinic visit, and will also receive an identical questionnaire to the first one by e-mail, by phone, or in person. Follow-up over time will continue (either in-person or over the phone) using the same questionnaires at approximately 6-month intervals. During follow-up, participant will be screened for new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
The proposed study does not involve formulating new diagnoses or directly offering treatment for neurological and/or psychiatric conditions. All patients admitted to PWH or other medical institutes will be treated according to the standard care at the corresponding institution, regardless of their decision to participate in this repository. Should results from this study lead to discovery of one or more factors associated with development of brain disease, the principal investigators, co-investigators, or study coordinator in the CUHK Brain Health Centre will inform, counsel and offer diagnostic and/or therapeutic recommendations to participants accordingly. The participants may be referred to relevant departments for follow-up clinical visits and may also be invited to participate in sister research projects at PWH/CUHK that have obtained ethics approval; if the participants are interested in any sister projects, they may be offered tests as the study procedures of these projects, including but not limited to blood tests, genetic tests, retinal imaging and brain imaging exams.
Our study aims to follow longitudinally individuals with or at risk for neurological and psychiatric disease, regardless of gender or sexual orientation. The investigators focus on enrolling adults as the vast majority of the neurological and psychiatric conditions of interest are diagnosed well into adulthood; indeed, most are age-related and particularly frequent among individuals in the fifth decade of life and beyond. Our study uniquely welcomes even individuals who are healthy from a brain standpoint, and offers them an opportunity to increase our scientific understanding of the early transition from normal to pathological brain functioning. As a result, the entire population as a whole stand to potentially benefit from the outcomes of the proposed research.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Red group | – | Behavioral: Neuro-QoL questionnaireThose participants who had established diagnosis of one or more neurological and/or psychiatric conditions Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire plus an additional subset of questions based on their clinical diagnosis should be done. |
| Yellow group | – | Behavioral: Neuro-QoL questionnaireThose participants who are high-risk to develop one or more neurological and/or psychiatric conditions, for example: 1. family history (first degree relative) one or more neurological and/or psychiatric conditions; 2. examination, imaging or laboratory findings consistent with pre-symptomatic stages of one or more neurological and/or psychiatric disorders. Baseline: The participants' medical history, signs, symptoms and diagnoses of neurological and/or psychiatric disorders would be recorded. Neuro-QoL questionnaire should be done. |
| Green group | – | Behavioral: Neuro-QoL questionnaireThose participants who are not meeting criteria for Red or Yellow groups, but interested in longitudinal research on maintenance and/or improvement of their brain health. Baseline: The participants' medical history would be recorded and Neuro-QoL questionnaire should be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Chinese ONLY 2. Hong Kong Resident
Key inclusion criteria (9 listed)
- Adult ≥ 18 years of age
- Fulfilling criteria for membership in one of these three groups:
- Subject provides informed consent by signing and dating the written informed consent form
- Subject is willing to answer health questionnaires and be followed longitudinally
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Neuro-QoL questionnaireFollow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals. During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above. | Behavioural | Green group, Red group, Yellow group |
Primary outcome
Risk factors contributing to neurological and psychiatric diseases
Time frame: December, 2038
The participants' electronic medical records and questionnaires done (either symptomatic or asymptomatic) would be compared with their follow-up electronic medical records/phone follow-up interview and questionnaires done over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data and health information may be sent out to our research collaborators at Massachusetts General Hospital and Harvard Medical School, where there is a sister institute for brain health for additional analysis.
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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.
Thomas Wai Hong LEUNG, FRCP principal investigator
Division of Neurology, The Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Stroke Syndrome, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Wai Hong LEUNG, FRCP (852-35053593, drtleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors contributing to neurological and psychiatric diseases (time frame: December, 2038). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2026.