Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02161172|
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : August 11, 2020
|Condition or disease|
|Mild Traumatic Brain Injury|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||360 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Cognitive, Functional, and Psychosocial Outcome After Mild Traumatic Brain Injury: a Cross-sectional Study at a Tertiary Care Trauma Center.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Mild traumatic brain injury
Traumatic brain injury patients with Glasgow coma score (GCS) of 13-15.
- Mini-Mental State Examination [ Time Frame: 6 months ]MMSE includes seven factors, namely: the time orientation factor (5 points), place orientation (5 points), immediate memory (3 points), short-term memory (3 points), calculation capabilities (5 points), verbal expression, naming and repetition (4 points), speech reading and understanding (4 points), graphic depiction (1 points). The scales for the description of cognitive function impairment were grouped into three levels of education: illiteracy (17 points), primary school (20 points) and middle school (24 points). The one with score below average was considered with cognitive function impairment.
- Activity of daily living scale [ Time Frame: 6 months ]The scale is divided into two parts: physical self-care ability, instrumental activities of daily living. 1 point for each option means normal; If 2~4 points for one option, he or she probably had ability decline; If two or more parts ≥3 points or total score≥ 22 points (14 questions), he or she exhibited living ability decline clearly.
- Hospital anxiety and depression Scale [ Time Frame: 6 months ]The scale includes 14 items and each has 0-3 points. The score of the former seven items > 7, indicating depression symptom; the later seven items > 7, indicating anxiety symptom.
- Symptom Check-List 90 [ Time Frame: 6 months ]This scale has been widely used to patients with neurosis, adjustment disorder and other slight mental psychological disorder. According to the national norm results, if the total score > 160, or the number of positive items > 43, or one factor score >2, we consider the positive screening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161172
|Shanghai Sixth People's Hospital|
|Shanghai, China, 200233|
|Study Director:||Heng-Li Tian, M.D., Ph.D.||Shanghai 6th People's Hospital|