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Clinical Trials/NCT02161172
NCT02161172
Completed
Not Applicable

Cognitive, Functional, and Psychosocial Outcome After Mild Traumatic Brain Injury: a Cross-sectional Study at a Tertiary Care Trauma Center.

Shanghai 6th People's Hospital1 site in 1 country360 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
Shanghai 6th People's Hospital
Enrollment
360
Locations
1
Primary Endpoint
Mini-Mental State Examination
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously. The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome. Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
May 2014
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hao Chen

Doctor

Shanghai 6th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • 18 \~ 60 years old
  • Education: primary school and above, who could understand the content of psychological test
  • History of brain trauma
  • No taking of antipsychotic or any other drugs affecting central nervous system before the test
  • Glasgow coma score (GCS) was 13-15

Exclusion Criteria

  • History of craniocerebral injury, brain disease, mental disease
  • With mental retardation
  • with other serious body diseases
  • History of drug and alcohol dependence
  • With color-blind or color weakness
  • Who had severe visual and auditory disorders after brain injury
  • Who failed or failed in completing the test effectively
  • With cognitive impairment caused by the damage of the unilateral frontal or bilateral lobes, or with language dysfunction caused by temporal lobe damage

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Activity of daily living scale(6 months)

Study Sites (1)

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