NCT02161172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

June 10, 2014

Last Update Submit

August 8, 2020

Conditions

Mild Traumatic Brain Injury

Keywords

Mild traumatic brain injuryCognitive outcomePsychological outcome

Outcome Measures

Primary Outcomes (1)

  • Mini-Mental State Examination

    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.

    6 months

Secondary Outcomes (1)

  • Activity of daily living scale

    6 months

Other Outcomes (2)

  • Hospital anxiety and depression Scale

    6 months

  • Symptom Check-List 90

    6 months

Study Arms (1)

Mild traumatic brain injury

Traumatic brain injury patients with Glasgow coma score (GCS) of 13-15.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • \~ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Heng-Li Tian, M.D., Ph.D.

    Shanghai 6th People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 11, 2014

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

CN(1)