Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT06245967
Eligibility Criteria:
Inclusion Criteria:
1. Age between 20 and 65, inclusive, for both males and females.
2. History of traumatic brain injury with a loss of consciousness lasting less than 30 minutes, initial Glasgow Coma Scale (GCS) score ranging from 13 to 15.
3. Presence of persistent post-concussion symptoms starting from the day of injury and lasting for more than ten days.
4. Complete consciousness or decision-making capacity at the time of enrollment.
5. Brain imaging through CT or MRI indicating the absence of significant midline shift, no evident damage to the brainstem (excluding the pyramidal tract), or thalamus. Each brain lobe lesion should not exceed 30% of the respective cerebral hemisphere.
Exclusion Criteria:
1. Individuals below 20 years or above 65 years of age, regardless of gender.
2. History of traumatic brain injury with a loss of consciousness exceeding 30 minutes, initial Glasgow Coma Scale (GCS) score less than 13.
3. Not a first-time occurrence of traumatic brain injury.
4. Brain imaging through CT or MRI revealing significant midline shift, evident damage to the brainstem or thalamus, with each brain lobe lesion exceeding 30% of the respective cerebral hemisphere.
5. Presence of comorbidities such as cancer, depression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT06245967
Study Brief:
Protocol Section:
NCT06245967