Trial · NCT07413562
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in global cognitive function assessed by the Mini-Mental State Examination(MMSE) | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | The MMSE will be used to evaluate global cognitive function. Assessments will be conducted by two trained occupational researchers who are blinded to group allocation and not involved in the intervention. |
| Secondary | Global cognitive function (MoCA) | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point screening tool evaluating multiple cognitive domains including attention, memory, language, executive function, and visuospatial ability. Higher scores indicate better cognitive performance, and a score below 26 suggests cognitive impairment. |
| Secondary | Verbal fluency | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Verbal fluency will be assessed using the Verbal Fluency Test, in which participants are asked to generate as many words as possible within 1 minute. The test evaluates language production and executive control, with higher word counts indicating better performance. |
| Secondary | Language function | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Language ability will be assessed using the Boston Naming Test, which requires participants to name a series of visually presented objects. Higher scores reflect better confrontation naming ability and language function. |
| Secondary | Visuospatial function | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Visuospatial ability will be assessed using the Rey-Osterrieth Complex Figure Test (RCFT), which evaluates visuospatial construction and visual memory through figure copying and recall tasks. Higher scores indicate better visuospatial performance. |
| Secondary | Verbal learning and memory | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Verbal learning and memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), a verbal learning task involving a 15-item word list learned over five trials. The delayed recall score represents the number of correctly recalled words (range: 0-15) after a 30-minute delay, with higher scores indicating better memory performance. |
| Secondary | Executive function | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Executive function will be assessed using the Stroop Test and Trail Making Test A/B. The Stroop Test evaluates inhibitory control and cognitive flexibility, while the Trail Making Test assesses processing speed (Part A) and set-shifting ability (Part B). Better executive function is reflected by higher accuracy and shorter completion time. |
| Secondary | Attention and working memory | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Attention and working memory will be assessed using the Digit Symbol Test and Digit Span Test. The Digit Symbol Test evaluates attention and processing speed, whereas the Digit Span Test assesses working memory capacity through forward and backward recall tasks. Higher scores indicate better cognitive performance. |
| Secondary | Neuropsychiatric symptoms | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Neuropsychiatric symptoms will be assessed using the Neuropsychiatric Inventory (NPI), which evaluates 12 neuropsychiatric symptom domains based on caregiver interviews, including both the caregiver's observations of patient behaviors and the associated caregiver distress. The total patient symptom score ranges from 0 to 144, and the caregiver distress score ranges from 0 to 60, with higher scores indicating greater symptom frequency, severity, and caregiver burden; a score of 0 represents the absence of symptoms or distress. |
| Secondary | Sleep quality | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of 19 self-rated items measuring seven domains of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleep medication, and (7) daytime dysfunction. The 19 items are aggregated into seven component scores, each ranging from 0 to 3, where 0 indicates no difficulty and 3 indicates severe difficulty. The component scores are summed to generate a global PSQI score ranging from 0 to 21, with higher scores indicating poorer overall sleep quality. |
| Secondary | Anxiety symptoms | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Anxiety symptoms will be assessed using the Hamilton Anxiety Scale (HAMA), a clinician-rated scale where higher scores indicate more severe anxiety symptoms. |
| Secondary | Depressive symptoms | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Depressive symptoms will be assessed using the Hamilton Depression Scale (HAMD), where higher scores indicate more severe depressive symptoms. |
| Secondary | Apathy | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Apathy will be assessed using the Modified Apathy Evaluation Scale (MAES), a questionnaire evaluating motivational and emotional engagement. The total score ranges from 0 to 42, with scores greater than 14 indicating apathy; higher scores represent more severe apathetic symptoms. |
| Secondary | Agitation | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Agitation will be assessed using the Cohen-Mansfield Agitation Inventory (CMAI), a 29-item observational scale designed to assess agitation behaviors related to dementia and delirium. The CMAI measures the frequency of agitated behaviors across multiple categories, with total scores ranging from 29 to 116; higher scores indicate more severe agitation. |
| Secondary | Level of consciousness | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Neurological status will be assessed using the Glasgow Coma Scale (GCS), a 15-point scale ranging from 3 to 15, where higher scores indicate better level of consciousness. |
| Secondary | Functional neurological outcome | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Functional neurological outcome will be assessed using the Modified Rankin Scale (mRS), which ranges from 0 to 6, where higher scores indicate worse functional outcome. A score of 0 indicates normal daily functioning, and a score of 6 indicates death. |
| Secondary | Activities of daily living | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Activities of daily living will be assessed using the Modified Barthel Index (MBI), a 100-point scale evaluating functional independence in basic daily activities. Higher scores indicate greater independence. Scores \<20 indicate very severe functional dependence with complete reliance on others; scores of 20-40 indicate severe dependence requiring substantial assistance; scores of 41-60 indicate moderate dependence; and scores \>60 indicate basic independence in daily living. |
| Secondary | Health-related quality of life | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36), which evaluates physical and mental health domains, where higher scores indicate better quality of life. |
| Secondary | Functional activities | Baseline (Day 7 after injury), 1 month after injury, and 3 months after injury. | Functional activities will be assessed using the Functional Activities Questionnaire (FAQ; range 0-30), with higher scores indicating worse functional performance. Scores ≤5 are considered normal, whereas scores ≥5 suggest impaired independence in home and community functioning. |
| Secondary | Neuroimaging outcomes | Baseline (Day 7 after injury) and 1 month after injury. | Functional connectivity of brain networks will be assessed using magnetoencephalography (MEG), with quantification of connectivity within the default mode network and executive control network. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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