Traumatic brain injury
Conditions
Interventions
Case group:None
Control group:None
Sponsors
Beijing Tiantan Hospital, Capital Medical University/The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Case group: Patients with traumatic brain injury Inclusion Criteria: (1) Age> = 18 years old, male or female; (2) patients with traumatic brain injury; (3) The Mini-Mental State Examination (MMSE) score was lower than normal, and the cut-off value for diagnosis was determined according to different education levels: illiteracy (uneducated) = 18 years old, male or female; (2) recent emotional stability; (3) Mini-Mental State Examination (MMSE) score was normal; (4) Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: Case group: Patients with traumatic brain injury Exclusion Criteria: (1) The study subject is in a lethargic state, coma, or persistent vegetative state; (2) the disease progresses rapidly or is accompanied by serious complications; (3) The subject has severe language dysfunction or/or bilateral upper limb motor function loss; (4) the study subject has severe visual and/or hearing impairment; (5) The subject has a severe mental disorder, physical weakness or other conditions (such as intolerance to the test or uncooperation, etc.); (6) Those who have a history of drug abuse within 6 months before screening or those who have used drugs within 3 months before screening; (7) Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons. Control group: family members or accompanying persons of patients in the same period Exclusion Criteria: (1) History of congenital or acquired central nervous system disease (including history of traumatic brain injury, cerebrovascular accident, etc.); (2) Those who have a history of drug abuse within 6 months before screening or who have used drugs within 3 months before screening; (3) Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluator Reliability of the LOTCA Battery;Retest Reliability of the LOTCA Battery;Internal Consistency Reliability of the LOTCA Battery;Content Validity of the LOTCA Battery;Construct Validity of the LOTCA Battery;Discriminative Validity of the LOTCA Battery;Change in LOTCA score from baseline after 3 months;Change in ADAS-Cog12 score from baseline after 3 months;Correlation between LOTCA score change from baseline and ADAS-Cog12 score change from baseline after 3 months;The area under the ROC curve and the sensitivity, specificity and Jorden index under the optimal threshold of the change value of LOTCA score from baseline; | — |
Countries
China
Contacts
Public ContactZheng Huaguang; Yu Rutong
Beijing Tiantan Hospital, Capital Medical University/The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed