Validation Study of Simplified Chinese Version of LOTCA Scale in the Assessment of Cognitive Impairment in Patients with Traumatic Brain Injury

Nanjing Broad Biopharmaceutical Ltd.

Status: Not yet enrolling

Conditions: Traumatic Brain Injury

Treatments: Other: Observation

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06850584

LOTCA-YZ-1

Details and patient eligibility

About

In this study, 300 patients aged ≥18 years old with traumatic brain injury (case group) and hospitalized patients without central nervous system disease or their family members and accompanying staff (control group) were selected as the study objects. At baseline, participants completed the Mini-mental State Examination (MMSE), the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery, the Glasgow Coma Scale (GCS), and the Alzheimer's Disease Rating Scale Cognitive Subscale (ADAS-Cog11). The evaluation process of the first LOTCA test was videotaped by a person. 2 weeks after the evaluation, the same two scale raters watched the video and rated it independently again. After 3 months, the subjects completed MMSE, LOTCA battery, GCS, ADAS-Cog11 assessment again.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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) <=19 points, primary school level <=22 points, junior high school level and above < = 26 points;
4. Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.

Control group: family members or accompanying persons of patients in the same period

Inclusion Criteria:

1. Age> = 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

• 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.

Trial design

300 participants in 2 patient groups

Case group

Treatment:

Other: Observation

Control group

Treatment:

Other: Observation