Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161172
• Other study ID #: 658214
• Status: Completed
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2020
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital anxiety and depression Scale	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.	6 months
Other	Symptom Check-List 90	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.	6 months
Primary	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	Activity of daily living scale	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.	6 months