Trial record 19 of 1740 for:    brain injury

Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hao Chen, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier:
NCT02161172
First received: June 10, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition
Mild Traumatic Brain Injury

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.

Resource links provided by NLM:


Further study details as provided by Shanghai 6th People's Hospital:

Primary Outcome Measures:
  • Mini-Mental State Examination [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Activity of daily living scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Hospital anxiety and depression Scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 360
Study Start Date: April 2012
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mild traumatic brain injury
Traumatic brain injury patients with Glasgow coma score (GCS) of 13-15.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

360 patients with mild traumatic brain injury were enrolled in this study. Their age ranged from 18 to 60 years, with mean age of 54.3 years. Types of trauma included scalp hematoma, scalp laceration, cerebral contusion, subarachnoid hemorrhage, cerebral concussion, epidural hematoma, subdural hematoma and skull fracture. Mechanisms of injury contained traffic accident, fall, industrial accident, etc. Occupation of patients included cadres, workers, farmers, individual, unemployed. Education: college or above, middle school, primary school.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02161172

Sponsors and Collaborators
Shanghai 6th People's Hospital
Investigators
Study Director: Heng-Li Tian, Ph.D. Shanghai Sixth People's Hospital
  More Information

No publications provided

Responsible Party: Hao Chen, Doctor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT02161172     History of Changes
Other Study ID Numbers: 658214
Study First Received: June 10, 2014
Last Updated: June 10, 2014
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai 6th People's Hospital:
Mild traumatic brain injury
Cognitive outcome
Psychological outcome

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014