Traumatic Brain InjuryNCT06850584
Validation Study of Simplified Chinese Version of LOTCA Scale in the Assessment of Cognitive Impairment in Patients with Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Nanjing Broad Biopharmaceutical Ltd. at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Observation
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age ≥18 years old, male or female, patients with traumatic brain injury (case group) and family members or caregivers of patients at the same time (control group).
Who may be able to join
- Case group: Patients with traumatic brain injury
- Age> = 18 years old, male or female;
- patients with traumatic brain injury;
- 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;
- 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
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- Age> = 18 years old, male or female;
- recent emotional stability;
- Mini-Mental State Examination (MMSE) score was normal;
- Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.
Who cannot join
- Case group: Patients with traumatic brain injury
- The study subject is in a lethargic state, coma, or persistent vegetative state;
- the disease progresses rapidly or is accompanied by serious complications;
- The subject has severe language dysfunction or/or bilateral upper limb motor function loss;
- the study subject has severe visual and/or hearing impairment;
- The subject has a severe mental disorder, physical weakness or other conditions (such as intolerance to the test or uncooperation, etc.);
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- Those who have a history of drug abuse within 6 months before screening or those who have used drugs within 3 months before screening;
- 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
- History of congenital or acquired central nervous system disease (including history of traumatic brain injury, cerebrovascular accident, etc.);
- Those who have a history of drug abuse within 6 months before screening or who have used drugs within 3 months before screening;
- Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huaian, Jiangsu
shu lian Ding, 0517-84911327
Suzhou Jiulong Hospital
Suzhou, Jiangsu
yi dong Jiang, +86 139 0154 1972
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
tong ru Yu, +86 180 5226 8155
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
zhu heng Zhang, +86 180 5106 1558
About this study
Official title: A Confirmatory Study of the Simplified Chinese Version of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) Battery (2nd Edition) to Assess Cognitive Impairment in Patients with Traumatic Brain Injury
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Observation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The study was observational and did not involve any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Not described Receives: Other: Observation | |
| Control group | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Measured: At baseline
Retest Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Measured: 2 weeks Later
Internal Consistency Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Measured: At baseline
Content Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Measured: At baseline
Construct Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Measured: At baseline
Discriminative Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Measured: At baseline
The change of Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery score from baseline values
Measured: 3 months later
The change of Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 score from baseline values
Measured: 3 months later
Correlation between LOTCA score change from baseline and ADAS-Cog11 score change from baseline
Measured: 3 months later
The area under ROC curve and the sensitivity, specificity and Jorden index under optimal threshold of LOTCA score change from baseline value
Measured: 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Broad Biopharmaceutical Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- tong ru Yu, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850584
- Sponsor's protocol ID
- LOTCA-YZ-1
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Study of the Simplified Chinese Version of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) Battery (2nd Edition) to Assess Cognitive Impairment in Patients with Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06850584
- Acronym / sponsor ID
- LOTCA-YZ-1
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Broad Biopharmaceutical Ltd.Research network
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Observation |
| Control group | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥18 years old, male or female, patients with traumatic brain injury (case group) and family members or caregivers of patients at the same time (control group).
Key inclusion criteria (10 listed)
- Case group: Patients with traumatic brain injury
- Age> = 18 years old, male or female;
- patients with traumatic brain injury;
- 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;
- Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.
Key exclusion criteria (12 listed)
- Case group: Patients with traumatic brain injury
- The study subject is in a lethargic state, coma, or persistent vegetative state;
- the disease progresses rapidly or is accompanied by serious complications;
- The subject has severe language dysfunction or/or bilateral upper limb motor function loss;
- the study subject has severe visual and/or hearing impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThe study was observational and did not involve any intervention. | Other | Case group, Control group |
Primary outcome
Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Time frame: At baseline
Retest Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Time frame: 2 weeks Later
Internal Consistency Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Time frame: At baseline
Content Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Time frame: At baseline
Construct Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Time frame: At baseline
Discriminative Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery
Time frame: At baseline
The change of Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery score from baseline values
Time frame: 3 months later
The change of Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 score from baseline values
Time frame: 3 months later
Correlation between LOTCA score change from baseline and ADAS-Cog11 score change from baseline
Time frame: 3 months later
The area under ROC curve and the sensitivity, specificity and Jorden index under optimal threshold of LOTCA score change from baseline value
Time frame: 3 months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huaian, China
tong ru Yu principal investigator
The Affiliated Hospital of Xuzhou Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Nanjing Broad Biopharmaceutical Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery (time frame: At baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.