Traumatic Brain InjuryNCT04161573
Irony Comprehension Ability of Chinese Speaking Patients With TBI
An observational study of Traumatic Brain Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims at understanding irony comprehension ability of Chinese speaking patients with TBI through a series of self-made stories. Each story contains two characters having a conversation, and one of them would give a figurative (which is, ironic) or literal statement at the end of the story. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Watching ironic stories
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Oct 2019to 31 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: NTUH
Who may be able to join
- Above 20 years old
- Chinese speaking people
- Diagnosed as TBI patients for over 6 months
- Having no other neurological and mental related problems
- Able to read with or without assistive device like glasses
Who cannot join
- Addicted to alcohol or drug morbid and postmorbid
- Having any communication disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 802
Hsin-Tzu Tseng, +886 978108036, s0480052@gmail.com
About this study
Official title: A Preliminary Study on Irony Comprehension Ability of Chinese Speaking Patients With Traumatic Brain Injury
This study aims at understanding irony comprehension ability of Chinese speaking patients with TBI through a series of self-made stories. Each story contains two characters having a conversation, and one of them would give a figurative (which is, ironic) or literal statement at the end of the story. The participants are asked to figure out its meaning.
Read the detailed description
The investigator plans to recruit TBI patients and control group whose gender and age accord with them, 15 people in each group. They would be asked to read the materials mentioned above displaying by a computer. It may take 30 minutes per time, and every participants only do once.
- Conditions
- Traumatic Brain Injury
- Being tested
- Watching ironic stories
- Keywords
- Irony comprehension
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching ironic storiesBehavioural
All the participants would be asked to watch a series of self-made stories which are figurative or literal. They have to figure out what is the real meaning of the character's statement. The whole procedure will be done with a computer.
| Study group | Role | What they receive |
|---|---|---|
| TBI group | 15 people in this group. Each should be post TBI for 6 months. Receives: Behavioral: Watching ironic stories | |
| Control group to TBI | 15 people in this group. Their gender and age accord with TBI group. Receives: Behavioral: Watching ironic stories | |
| Aging group 1- 20 to 39 | Normal people whose age range from 20 to 39. Receives: Behavioral: Watching ironic stories | |
| Aging group 2- 40 to 59 | Normal people whose age range from 40 to 59. Receives: Behavioral: Watching ironic stories | |
| Aging group 3- above 60 | Normal people whose age are above 60. Receives: Behavioral: Watching ironic stories |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBI group gets lower scores
We assume that TBI group can't comprehend ironic statement as well as their control group. Therefore, they may get lower score than their normal- health control group.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start10 Oct 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chun Chih, PhD, Study chair, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161573
- Sponsor's protocol ID
- 201908029RINA
- Status last verified
- Oct 2019
- First submitted
- 10 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Angeleri R, Bosco FM, Zettin M, Sacco K, Colle L, Bara BG. Communicative impairment in traumatic brain injury: a complete pragmatic assessment. Brain Lang. 2008 Dec;107(3):229-45. doi: 10.1016/j.bandl.2008.01.002. Epub 2008 Feb 11.
PubMed 18267340Carlomagno S, Giannotti S, Vorano L, Marini A. Discourse information content in non-aphasic adults with brain injury: a pilot study. Brain Inj. 2011;25(10):1010-8. doi: 10.3109/02699052.2011.605097.
PubMed 21812587
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on Irony Comprehension Ability of Chinese Speaking Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04161573
- Acronym / sponsor ID
- 201908029RINA
- Conditions
- Traumatic Brain Injury
- Keywords
- Irony comprehension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 13 Nov 2019 (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.
This study aims at understanding irony comprehension ability of Chinese speaking patients with TBI through a series of self-made stories. Each story contains two characters having a conversation, and one of them would give a figurative (which is, ironic) or literal statement at the end of the story. The participants are asked to figure out its meaning.
Detailed description
The investigator plans to recruit TBI patients and control group whose gender and age accord with them, 15 people in each group. They would be asked to read the materials mentioned above displaying by a computer. It may take 30 minutes per time, and every participants only do once.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TBI group | – | Behavioral: Watching ironic stories15 people in this group. Each should be post TBI for 6 months. |
| Control group to TBI | – | Behavioral: Watching ironic stories15 people in this group. Their gender and age accord with TBI group. |
| Aging group 1- 20 to 39 | – | Behavioral: Watching ironic storiesNormal people whose age range from 20 to 39. |
| Aging group 2- 40 to 59 | – | Behavioral: Watching ironic storiesNormal people whose age range from 40 to 59. |
| Aging group 3- above 60 | – | Behavioral: Watching ironic storiesNormal people whose age are above 60. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NTUH
Key inclusion criteria (5 listed)
- Above 20 years old
- Chinese speaking people
- Diagnosed as TBI patients for over 6 months
- Having no other neurological and mental related problems
- Able to read with or without assistive device like glasses
Key exclusion criteria (2 listed)
- Addicted to alcohol or drug morbid and postmorbid
- Having any communication disorders
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 |
|---|---|---|
| Watching ironic storiesAll the participants would be asked to watch a series of self-made stories which are figurative or literal. They have to figure out what is the real meaning of the character's statement. The whole procedure will be done with a computer. | Behavioural | Aging group 1- 20 to 39, Aging group 2- 40 to 59, Aging group 3- above 60, Control group to TBI, TBI group |
Primary outcome
TBI group gets lower scores
Time frame: 2 months
We assume that TBI group can't comprehend ironic statement as well as their control group. Therefore, they may get lower score than their normal- health control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Results publication: PubMed 18267340Angeleri R, Bosco FM, Zettin M, Sacco K, Colle L, Bara BG. Communicative impairment in traumatic brain injury: a complete pragmatic assessment. Brain Lang. 2008 Dec;107(3):229-45. doi: 10.1016/j.bandl.2008.01.002. Epub 2008 Feb 11.
- Results publication: PubMed 21812587Carlomagno S, Giannotti S, Vorano L, Marini A. Discourse information content in non-aphasic adults with brain injury: a pilot study. Brain Inj. 2011;25(10):1010-8. doi: 10.3109/02699052.2011.605097.
- Individual participant dataSharing planned: Undecided
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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.
Yu-Chun Chih, PhD study chair
Chung Shan Medical University
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 Traumatic Brain Injury, 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 5 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 13 Nov 2019. 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?
Contact Hsin-Tzu Tseng (+886 978108036, s0480052@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBI group gets lower scores (time frame: 2 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 NCT04161573, which also lists 2 linked publications.
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 13 Nov 2019.