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:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT05048966
Eligibility Criteria:
For individuals with moderate/severe TBI:
Inclusion Criteria:
* age 18-64
* at least one year post injury
* can read and speak English fluently
* has a support person who is willing to participate in the study
Exclusion Criteria:
* has had a prior stroke or neurological disease other than TBI
* has unstable or uncontrolled seizures
* has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
* current alcohol and/or drug use that interferes with ability to carry out common everyday functions
For individuals with chronic mild TBI:
Inclusion Criteria:
* age 18-64
* at least 3 months post-injury
* can read and speak English fluently
* has a support person who is willing to participate in the study
Exclusion Criteria:
* has had a prior stroke or neurological disease other than mild TBI
* has unstable or uncontrolled seizures
* has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
* current alcohol and/or drug use that interferes with ability to carry out common everyday functions
For Individuals with Alzheimer's Disease Related Dementias (ADRD)
Inclusion Criteria:
* age 65 and older
* at least one-year post-diagnosis
* can read and speak English fluently
* has a support person who is willing to participate in this study
Exclusion Criteria:
* has had a prior stroke or neurological disease other than ADRD
* has unstable or uncontrolled seizures
* has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
* current alcohol and/or drug use that interferes with ability to carry out common everyday functions
For Support Persons:
Inclusion Criteria:
* is the support person of an individual with moderate/severe TBI, chronic mild TBI or ADRD who is willing to participate in the study
* can read and speak English fluently
Exclusion Criteria:
* has a significant neurological history (e.g. stroke or multiple sclerosis)
* has unstable or uncontrolled seizures
* has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
* current alcohol and/or drug use that interferes with ability to carry out common everyday functions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05048966
Study Brief:
Protocol Section:
NCT05048966