Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

NCT ID: NCT02161172

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Mild traumatic brain injury

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hao Chen

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heng-Li Tian, M.D., Ph.D.

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Locations

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Shanghai Sixth People's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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658214

Identifier Type: -

Identifier Source: org_study_id

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