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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04161573
Other study ID # 201908029RINA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 10, 2019
Est. completion date January 31, 2020

Study information

Verified date October 2019
Source National Taiwan University Hospital
Contact Hsin-Tzu Tseng
Phone +886 978108036
Email s0480052@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The participants are asked to figure out its meaning.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Addicted to alcohol or drug morbid and postmorbid

- Having any communication disorders

Study Design


Intervention

Behavioral:
Watching ironic stories
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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

Carlomagno 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
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