Primary Disease or Condition Being Studied, or Focus of the StudyNCT05620810
Neuropsychiatric Symptoms in Spontaneous Intracerebral Hemorrhage Survivors
An observational study of Primary Disease or Condition Being Studied, or Focus of the Study, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Compared to the United Kingdom and the United States, Spontaneous non-traumatic intracerebral hemorrhage (ICH) is more common among people in Taiwan. The prevalence rate of ICH was 14.0% for people aged 36 years or older in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Disease or Condition Being Studied, or Focus of the Study
- What is being tested?
- neuropsychiatric symptoms
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be recruited participants from National Taiwan University Hospital Bei-Hu branch and National Taiwan University Hospital Neurology Clinic. We aim to enroll respectively maximum number of 60 patients who had previous spontaneous ICH.
Who may be able to join
- The patient is older than 20-year-old (older than 18-year-old from Jan 1st, 2023) with a past medical history of spontaneous intracerebral hemorrhage.
- The weight of patient is over 50 Kilograms
- Patient agrees to participate in the study
Who cannot join
- Patients who experience acute phase of stroke or neurological disorders, or vision loss and hearing impairment
- Patient cannot cooperate with the interview including those with aphasia, conscious disturbance or bedridden status
Trial locations and contacts
1 site in 1 country.
About this study
Compared to the United Kingdom and the United States, Spontaneous non-traumatic intracerebral hemorrhage (ICH) is more common among people in Taiwan. The prevalence rate of ICH was 14.0% for people aged 36 years or older in Taiwan. Primary ICH originates from the spontaneous rupture of small vessels damaged by chronic hypertension or cerebral amyloid angiopathy (CAA). Emotional disturbances are frequent symptoms in stroke survivors and negatively impact on functional recovery, the patient's quality of life and are distressing for both the patients and their caregivers. Furthermore, the emotional disturbances are associated with impaired cognitive. However, these issues are often unnoticed and most of the studies had been performed in ischemic stroke survivors rather than in patients with ICH.
In this study, we will be recruited participants from National Taiwan University Hospital Bei-Hu branch and National Taiwan University Hospital. We aim to enroll respectively maximum number of 60 patients who had previous spontaneous ICH. Each participant will receive neuropsychiatric assessment, cognitive screening tests, domain-specific cognitive tests, a questionnaire for their quality of life and blood drawing for ApoE genotyping. The main aims of this study include (1) To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors (2) To investigate the impact of non-cognitive neuropsychiatric issues on the cognitive functions and quality of life in ICH survivors. Our results may remind clinicians to pay more attention to the early diagnosis and effective management of neuropsychiatric symptoms to improve clinical outcomes.
- Being tested
- neuropsychiatric symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychiatric symptomsBehavioural
neuropsychiatric symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Disease or Condition Being Studied, or Focus of the StudyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620810
- Sponsor's protocol ID
- 202210006RIND
- Status last verified
- Oct 2022
- First submitted
- 11 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychiatric Symptoms in Spontaneous Intracerebral Hemorrhage Survivors
- ClinicalTrials.gov ID
- NCT05620810
- Acronym / sponsor ID
- 202210006RIND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Nov 2022 (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.
Compared to the United Kingdom and the United States, Spontaneous non-traumatic intracerebral hemorrhage (ICH) is more common among people in Taiwan. The prevalence rate of ICH was 14.0% for people aged 36 years or older in Taiwan. Primary ICH originates from the spontaneous rupture of small vessels damaged by chronic hypertension or cerebral amyloid angiopathy (CAA). Emotional disturbances are frequent symptoms in stroke survivors and negatively impact on functional recovery, the patient's quality of life and are distressing for both the patients and their caregivers. Furthermore, the emotional disturbances are associated with impaired cognitive. However, these issues are often unnoticed and most of the studies had been performed in ischemic stroke survivors rather than in patients with ICH.
In this study, we will be recruited participants from National Taiwan University Hospital Bei-Hu branch and National Taiwan University Hospital. We aim to enroll respectively maximum number of 60 patients who had previous spontaneous ICH. Each participant will receive neuropsychiatric assessment, cognitive screening tests, domain-specific cognitive tests, a questionnaire for their quality of life and blood drawing for ApoE genotyping. The main aims of this study include (1) To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors (2) To investigate the impact of non-cognitive neuropsychiatric issues on the cognitive functions and quality of life in ICH survivors. Our results may remind clinicians to pay more attention to the early diagnosis and effective management of neuropsychiatric symptoms to improve clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be recruited participants from National Taiwan University Hospital Bei-Hu branch and National Taiwan University Hospital Neurology Clinic. We aim to enroll respectively maximum number of 60 patients who had previous spontaneous ICH.
Key inclusion criteria (3 listed)
- The patient is older than 20-year-old (older than 18-year-old from Jan 1st, 2023) with a past medical history of spontaneous intracerebral hemorrhage.
- The weight of patient is over 50 Kilograms
- Patient agrees to participate in the study
Key exclusion criteria (2 listed)
- Patients who experience acute phase of stroke or neurological disorders, or vision loss and hearing impairment
- Patient cannot cooperate with the interview including those with aphasia, conscious disturbance or bedridden status
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 |
|---|---|---|
| neuropsychiatric symptomsneuropsychiatric symptoms | Behavioural | – |
Primary outcome
To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Disease or Condition Being Studied, or Focus of the Study, run by National Taiwan University 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 3 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 Nov 2022. 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?
Results are not available in the source record.
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?
To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors (time frame: 1 year). 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 17 Nov 2022.