DeliriumNMCHYISNCT06854497
The Impact of Non-motor Symptom on the Outcome of Stroke Subjects
An observational study of Delirium and Fatigue, run by Chiayi Christian Hospital at 1 site in Taiwan.
Trial summary
The most common symptoms of stroke were focal weakness, hemiparesis, speech disturbance, diplopia and ataxia. Beside those symptoms, there are still many symptoms occurring after stroke, which may affect the life quality of participants. Compared to motor symptoms, the study of these non-motor symptoms was too small. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Delirium, Fatigue, Depression
- What is being tested?
- MMSE (Mini-Mental State Examination),NIHSS (NIH Stroke Scale) and mRS (Mordified Rankin Score), Confusion Assessment Methods (CAM), PSQI Pittsburgh Sleep Quality Index, Respiratory polygraphy
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2026
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients admitted to hospital within 1 week of stroke onset. Brain magnetic resonance inaging confirmed ischemic. Patient age between 20 and 90 years old were included the study. Exclusion criteria were 1. patient older than 90 years old. 2. patient cannot communication included severe dementia, aphasia and consciousness disturbance. 3. Patient do not agree participate the study.
Who may be able to join
- 1. Acute stroke within 1 week.
- 2. Ischemic stroke was confirmed by magnetic resonance imaging.
Who cannot join
- 1. Patient not agree the study.
- 2. Patient cannot communication.
- 3. Severe dementia (mmse \<10)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, Taiwan, 600
About this study
Official title: The Impact of Non-motor Symptom on the Outcome of Stroke Patients: A Prospective Observational
The most common symptoms of stroke were focal weakness, hemiparesis, speech disturbance, diplopia and ataxia. Beside those symptoms, there are still many symptoms occurring after stroke, which may affect the life quality of participants. Compared to motor symptoms, the study of these non-motor symptoms was too small.
At present, the most reported non-motor symptoms after stroke are sleep disorder, depression and post-stroke pain. There are still many symptoms that were not investigated.
Read more
The study investigates the prevalence of non-motor syndromes in acute ischemic stroke patients and the impact of these syndromes on the outcome of ischemic stroke patients. The non-motor syndromes that were researched include dizziness, pain, skin lesions, sensory impairment, fever, infection, delirium, depression, insomnia, confusion, delirium and headache.
Delirium may occur after stroke. Delirium may impair the mentality, thinking, attention and consciousness level of participants. There are many causes reported attributed to confusion including infection, old age, stroke, hemorrhage… Early diagnosis and early treatment for confusion may improve outcome and decrease mortality in stroke populations. One of the aims of the study is to investigate the prevalence, causes and outcome of treatment in stroke populations who hospitalized to the hospital. Fatigue is a feeling of tiredness or lack of energy. Fatigue is not the same as the feeling drowsy or sleepy. When a person is fatigued, they lose motivation and energy. Fatigue may be mild to severe. It may be related to a physical or mental health condition. The study investigates the prevalence and impact of fatigue on stroke populations' outcomes. In depression, a person experiences a loss of pleasure or interest in activities and feels sad, irritable, and empty. Post-stroke depression is common. When a stroke person has a depressed mood, they may have no motivation for activity. This may interfere with physical therapy and affect the outcome of a stroke. The study investigates post-stroke depression prevalence and impact. The study investigates the prevalence and impact of sleep apnea on stroke outcome.
Read the detailed description
Delirium may occur after stroke. Delirium may impair the mentality, thinking, attention and consciousness level of participants. There are many causes reported attributed to confusion including infection, old age, stroke, hemorrhage… Early diagnosis and early treatment for confusion may improve outcome and decrease mortality in stroke populations. One of the aims of the study is to investigate the prevalence, causes and outcome of treatment in stroke populations who undergo hospitalization to the hospital. Fatigue is a feeling of tiredness or lack of energy. Fatigue is not the same as being drowsy or sleepy. When a person is fatigued, they lose motivation and energy. Fatigue may be mild to severe. It may be related to a physical or mental health condition. The aim of the study is to investigate the prevalence and impact of fatigue on the outcome of stroke populations. Depression is a person experiencing depressed mood (saddy, irritable, and empty) or loss of pleasure or interest in activities. Post-stroke depression is common. When a stroke person has a depressed mood, they lose motivation in activity which may interfere with physical therapy and affect stroke outcomes. The study explores the prevalence and impact of post-stroke depression.
Methods The study included all potentially participants who were referred to the hospital with a stroke. Exclusion criteria: 1. Age less than 20 years. 2. Severe dementia (MMSE lower than 10. 3. No agree to participate in the study.
All participants were followed-up for 3 months after stroke onset. During the acute ischemic stroke stage, researchers will evaluate participants' skin, ask participants about symptoms of headache, pain, dizziness, sensory complaint, sleep condition, evaluate participants' emotion condition everyday till discharge and follow up till 3 months after stroke onset. The study also researches the impact of non-motor syndromes on stroke outcomes.
The scales used to evaluate non-motor syndromes were listed.
Delirium study: Confusion Assessment Methods (CAM) is used to evaluate the consciousness of participants admitted to ICU, Brief Confusion Assessment Methods (bCAM) is used to evaluate the consciousness of participants who are not admitted to ICU.
DSM-V diagnosis criteria of confusion were used to diagnose confusion. The time of confusion evaluation is every day in the first week after stroke onset. Investigator also evaluates MMSE, NIHSS, mRS.
Fatigue study Fatigue severity Index was used to evaluate fatigue severity. Fatigue was evaluated in the first week, and 3 months after the stroke. Investigator also evaluates MMSE, NIHSS, mRS.
Post-stroke depression study Beck Depression Inventory and Hospital anxiety and depression Scale were used to evaluate the mood of the participants. Participants' mood was evaluated in the first week, and 3 months after stroke onset. Investigator also evaluates MMSE, NIHSS and mRS. MMSE was evaluated on the first day of admission. NIHSS was evaluated on the first day of admission and discharge. mRS was evaluated at day of discharge, and 3 months. The Berlin Questionnaire was used to evaluate the risk of sleep apnea. Respiratory polygraphy was used to evaluate sleep apnea during admission.
Description of the scale were used in the study A. Confusion Assessment Methods (CAM)
CAM is based on four key diagnostic features:
- Acute Onset and Fluctuating Course - The sudden development of confusion with variations in severity over time.
- Inattention - Difficulty focusing or maintaining attention.
- Disorganized Thinking - Illogical or incoherent thoughts.
- Altered Level of Consciousness - A state of hyper alertness or lethargy. For a positive delirium diagnosis, participant needs present with first two features along with either the third or fourth.
- Mini-Mental State Examination (MMSE) MMSE
- MMSE consists of 30 questions divided into five cognitive domains, Include orientation, registration, attention and calculation, recall, language and praxis.
- 24 - 30: Normal cognitive function, 18 - 23: Mild cognitive impairment 10 - 17: Moderate cognitive impairment, 0 - 9: Severe cognitive impairment.
- National Institutes of Health Stroke Scale (NIHSS)
- NIHSS consists of 11 components, total score range from 0 to 42.
- 0: No stroke, 1-4: Minor stroke, 5-15: Mo derate stroke, 15-20: Moderate/severe stroke, 21-42: Severe stroke
- Modified Rankin Score The score of 0-3 indicates mild to moderate disability. Score of 4-5 indicates severe disability. 6 indicates death.
- Berlin Questionnaire The Berlin Questionnaire consists of 10 questions divided into three categories. According to the response, participants were classified as high risk or low risk of obstructive sleep apnea.
- Fatigue Severity Scale (FSS) The FSS questionnaire contains nine statements. Participants read each statement and circle a number from 1 to 7. FSS score over 36 is considered to have fatigue.
- Apnea-hypopnea index (AHI) Respiratory polygraphy was used to evaluate sleep apnea within the first Week after stroke onset. AHI over 15 is considered as sleep apnea.
- 36-Item Short Form Health Survey (SF-36) SF-36 is used to evaluate quality of life.
SF-36 consists of 36 questions that assess eight health domains:
- Physical Functioning (PF) - Measures limitations in performing physical activities (e.g., walking, climbing stairs).
- Role Physical (RP) - Assesses role limitations due to physical health problems.
- Bodily Pain (BP) - Evaluates the impact of pain on daily activities.
- General Health (GH) - Measures overall personal health perceptions.
- Vitality (VT) - Assesses energy levels and fatigue.
- Social Functioning (SF) - Evaluates the impact of health on social activities.
- Role Emotional (RE) - Measures role limitations due to emotional problems.
- Mental Health (MH) - Assesses psychological well-being and distress. Each domain is scored on a 0 to 100 scale, where higher scores indicate Better health status.
Outcome measure Primary outcome Functional outcome Modified Rankin Score (mRS) is used to evaluate the functional outcome of the participants up to 3 months after stroke onset.
The mRS score (0 to 6), scores of 0-3 indicate mild to moderate disability. a score of 4-5 indicates severe disability, and 6 indicates death. In the study, a mRS over 2 is considered poor outcome.
Secondary outcome Quality of life 36-Item Short Form Health Survey (SF-36) used to evaluate quality of life for 3 months. SF-36 consists of 36 questions that assess eight health domains. Each domain is scored on a 0 to 100 scale, where higher scores indicate better health status.
A score lower than 60 in a domain is considered as low quality in the health domain..
- Conditions
- Delirium, Fatigue, Depression, Insomnia, Sleep Apnea Syndrome (OSAS), Skin Lesion
- Being tested
- MMSE (Mini-Mental State Examination),NIHSS (NIH Stroke Scale) and mRS (Mordified Rankin Score), Confusion Assessment Methods (CAM), PSQI Pittsburgh Sleep Quality Index, Respiratory polygraphy
- Keywords
- skin lesion, stroke, delirium, fatigue, sleep disorder, depression, outcomes
- Medical subject headings
- Delirium, Fatigue, Depression, Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSE (Mini-Mental State Examination),NIHSS (NIH Stroke Scale) and mRS (Mordified Rankin Score), Confusion Assessment Methods (CAM), PSQI Pittsburgh Sleep Quality Index, Respiratory polygraphyDiagnostic test
Respiratory polygraphy will be performed during acute stroke period, to evaluate the relationship between sleep apnea and stroke evolution.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Modified Rankin Score (mRS) is used to evaluate the functional outcome of the participants up to 3 months after stroke onset.
The mRS score (0 to 6), scores of 0-3 indicate mild to moderate disability. a score of 4-5 indicates severe disability, and 6 indicates death. In the study, a mRS over 2 is considered poor outcome.
Measured: Participants are followed-up up to 3 months after stroke onset.
Secondary outcomes (1)
Quality of life in ischemic stroke patients
Quality of life 36-Item Short Form Health Survey (SF-36) used to evaluate quality of life for 3 months. SF-36 consists of 36 questions that assess eight health domains. Each domain is scored on a 0 to 100 scale, where higher scores indicate better health status. A score lower than 60 in a domain is considered as low quality in the health domain.
Measured: follow patient daily activity of life at 3 month after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheung-Ter Ong, Master, Principal investigator, Ditmanson Medical Foundation Chiayi Christian Hospital Neurologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854497
- Sponsor's protocol ID
- CYCH2765041
- Other IDs
- R112-03
- Acronym
- NMCHYIS
- Status last verified
- Feb 2025
- First submitted
- 5 Sep 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Non-motor Symptom on the Outcome of Stroke Patients: A Prospective Observational
- ClinicalTrials.gov ID
- NCT06854497
- Acronym / sponsor ID
- NMCHYIS / CYCH2765041
- Conditions
- Delirium, Fatigue, Depression, Insomnia, Sleep Apnea Syndrome (OSAS), Skin Lesion
- Keywords
- skin lesion, stroke, delirium, fatigue, sleep disorder, depression, outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (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 most common symptoms of stroke were focal weakness, hemiparesis, speech disturbance, diplopia and ataxia. Beside those symptoms, there are still many symptoms occurring after stroke, which may affect the life quality of participants. Compared to motor symptoms, the study of these non-motor symptoms was too small.
At present, the most reported non-motor symptoms after stroke are sleep disorder, depression and post-stroke pain. There are still many symptoms that were not investigated.
The study investigates the prevalence of non-motor syndromes in acute ischemic stroke patients and the impact of these syndromes on the outcome of ischemic stroke patients. The non-motor syndromes that were researched include dizziness, pain, skin lesions, sensory impairment, fever, infection, delirium, depression, insomnia, confusion, delirium and headache.
Delirium may occur after stroke. Delirium may impair the mentality, thinking, attention and consciousness level of participants. There are many causes reported attributed to confusion including infection, old age, stroke, hemorrhage… Early diagnosis and early treatment for confusion may improve outcome and decrease mortality in stroke populations. One of the aims of the study is to investigate the prevalence, causes and outcome of treatment in stroke populations who hospitalized to the hospital. Fatigue is a feeling of tiredness or lack of energy. Fatigue is not the same as the feeling drowsy or sleepy. When a person is fatigued, they lose motivation and energy. Fatigue may be mild to severe. It may be related to a physical or mental health condition. The study investigates the prevalence and impact of fatigue on stroke populations' outcomes. In depression, a person experiences a loss of pleasure or interest in activities and feels sad, irritable, and empty. Post-stroke depression is common. When a stroke person has a depressed mood, they may have no motivation for activity. This may interfere with physical therapy and affect the outcome of a stroke. The study investigates post-stroke depression prevalence and impact. The study investigates the prevalence and impact of sleep apnea on stroke outcome.
Detailed description
Delirium may occur after stroke. Delirium may impair the mentality, thinking, attention and consciousness level of participants. There are many causes reported attributed to confusion including infection, old age, stroke, hemorrhage… Early diagnosis and early treatment for confusion may improve outcome and decrease mortality in stroke populations. One of the aims of the study is to investigate the prevalence, causes and outcome of treatment in stroke populations who undergo hospitalization to the hospital. Fatigue is a feeling of tiredness or lack of energy. Fatigue is not the same as being drowsy or sleepy. When a person is fatigued, they lose motivation and energy. Fatigue may be mild to severe. It may be related to a physical or mental health condition. The aim of the study is to investigate the prevalence and impact of fatigue on the outcome of stroke populations. Depression is a person experiencing depressed mood (saddy, irritable, and empty) or loss of pleasure or interest in activities. Post-stroke depression is common. When a stroke person has a depressed mood, they lose motivation in activity which may interfere with physical therapy and affect stroke outcomes. The study explores the prevalence and impact of post-stroke depression.
Methods The study included all potentially participants who were referred to the hospital with a stroke. Exclusion criteria: 1. Age less than 20 years. 2. Severe dementia (MMSE lower than 10. 3. No agree to participate in the study.
All participants were followed-up for 3 months after stroke onset. During the acute ischemic stroke stage, researchers will evaluate participants' skin, ask participants about symptoms of headache, pain, dizziness, sensory complaint, sleep condition, evaluate participants' emotion condition everyday till discharge and follow up till 3 months after stroke onset. The study also researches the impact of non-motor syndromes on stroke outcomes.
The scales used to evaluate non-motor syndromes were listed.
Delirium study: Confusion Assessment Methods (CAM) is used to evaluate the consciousness of participants admitted to ICU, Brief Confusion Assessment Methods (bCAM) is used to evaluate the consciousness of participants who are not admitted to ICU.
DSM-V diagnosis criteria of confusion were used to diagnose confusion. The time of confusion evaluation is every day in the first week after stroke onset. Investigator also evaluates MMSE, NIHSS, mRS.
Fatigue study Fatigue severity Index was used to evaluate fatigue severity. Fatigue was evaluated in the first week, and 3 months after the stroke. Investigator also evaluates MMSE, NIHSS, mRS.
Post-stroke depression study Beck Depression Inventory and Hospital anxiety and depression Scale were used to evaluate the mood of the participants. Participants' mood was evaluated in the first week, and 3 months after stroke onset. Investigator also evaluates MMSE, NIHSS and mRS. MMSE was evaluated on the first day of admission. NIHSS was evaluated on the first day of admission and discharge. mRS was evaluated at day of discharge, and 3 months. The Berlin Questionnaire was used to evaluate the risk of sleep apnea. Respiratory polygraphy was used to evaluate sleep apnea during admission.
Description of the scale were used in the study A. Confusion Assessment Methods (CAM)
CAM is based on four key diagnostic features:
- Acute Onset and Fluctuating Course - The sudden development of confusion with variations in severity over time.
- Inattention - Difficulty focusing or maintaining attention.
- Disorganized Thinking - Illogical or incoherent thoughts.
- Altered Level of Consciousness - A state of hyper alertness or lethargy. For a positive delirium diagnosis, participant needs present with first two features along with either the third or fourth.
- Mini-Mental State Examination (MMSE) MMSE
- MMSE consists of 30 questions divided into five cognitive domains, Include orientation, registration, attention and calculation, recall, language and praxis.
- 24 - 30: Normal cognitive function, 18 - 23: Mild cognitive impairment 10 - 17: Moderate cognitive impairment, 0 - 9: Severe cognitive impairment.
- National Institutes of Health Stroke Scale (NIHSS)
- NIHSS consists of 11 components, total score range from 0 to 42.
- 0: No stroke, 1-4: Minor stroke, 5-15: Mo derate stroke, 15-20: Moderate/severe stroke, 21-42: Severe stroke
- Modified Rankin Score The score of 0-3 indicates mild to moderate disability. Score of 4-5 indicates severe disability. 6 indicates death.
- Berlin Questionnaire The Berlin Questionnaire consists of 10 questions divided into three categories. According to the response, participants were classified as high risk or low risk of obstructive sleep apnea.
- Fatigue Severity Scale (FSS) The FSS questionnaire contains nine statements. Participants read each statement and circle a number from 1 to 7. FSS score over 36 is considered to have fatigue.
- Apnea-hypopnea index (AHI) Respiratory polygraphy was used to evaluate sleep apnea within the first Week after stroke onset. AHI over 15 is considered as sleep apnea.
- 36-Item Short Form Health Survey (SF-36) SF-36 is used to evaluate quality of life.
SF-36 consists of 36 questions that assess eight health domains:
- Physical Functioning (PF) - Measures limitations in performing physical activities (e.g., walking, climbing stairs).
- Role Physical (RP) - Assesses role limitations due to physical health problems.
- Bodily Pain (BP) - Evaluates the impact of pain on daily activities.
- General Health (GH) - Measures overall personal health perceptions.
- Vitality (VT) - Assesses energy levels and fatigue.
- Social Functioning (SF) - Evaluates the impact of health on social activities.
- Role Emotional (RE) - Measures role limitations due to emotional problems.
- Mental Health (MH) - Assesses psychological well-being and distress. Each domain is scored on a 0 to 100 scale, where higher scores indicate Better health status.
Outcome measure Primary outcome Functional outcome Modified Rankin Score (mRS) is used to evaluate the functional outcome of the participants up to 3 months after stroke onset.
The mRS score (0 to 6), scores of 0-3 indicate mild to moderate disability. a score of 4-5 indicates severe disability, and 6 indicates death. In the study, a mRS over 2 is considered poor outcome.
Secondary outcome Quality of life 36-Item Short Form Health Survey (SF-36) used to evaluate quality of life for 3 months. SF-36 consists of 36 questions that assess eight health domains. Each domain is scored on a 0 to 100 scale, where higher scores indicate better health status.
A score lower than 60 in a domain is considered as low quality in the health domain..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients admitted to hospital within 1 week of stroke onset. Brain magnetic resonance inaging confirmed ischemic. Patient age between 20 and 90 years old were included the study. Exclusion criteria were 1. patient older than 90 years old. 2. patient cannot communication included severe dementia, aphasia and consciousness disturbance. 3. Patient do not agree participate the study.
Key inclusion criteria (2 listed)
- 1. Acute stroke within 1 week.
- 2. Ischemic stroke was confirmed by magnetic resonance imaging.
Key exclusion criteria (3 listed)
- 1. Patient not agree the study.
- 2. Patient cannot communication.
- 3. Severe dementia (mmse \<10)
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 |
|---|---|---|
| MMSE (Mini-Mental State Examination),NIHSS (NIH Stroke Scale) and mRS (Mordified Rankin Score), Confusion Assessment Methods (CAM), PSQI Pittsburgh Sleep Quality Index, Respiratory polygraphyRespiratory polygraphy will be performed during acute stroke period, to evaluate the relationship between sleep apnea and stroke evolution. | Diagnostic test | – |
Primary outcome
Functional outcome
Time frame: Participants are followed-up up to 3 months after stroke onset.
Modified Rankin Score (mRS) is used to evaluate the functional outcome of the participants up to 3 months after stroke onset. The mRS score (0 to 6), scores of 0-3 indicate mild to moderate disability. a score of 4-5 indicates severe disability, and 6 indicates death. In the study, a mRS over 2 is considered poor outcome.
1 secondary outcome
Quality of life in ischemic stroke patients
Time frame: follow patient daily activity of life at 3 month after stroke
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 3 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cheung-Ter Ong, Master principal investigator
Ditmanson Medical Foundation Chiayi Christian Hospital Neurologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Fatigue, run by Chiayi Christian Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: Participants are followed-up up to 3 months after stroke onset.). 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 3 Mar 2025.