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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT01816061
Eligibility Criteria:
Inclusion Criteria:
* TBI of at least mild severity using criteria related to disturbance of consciousness (VHA TBI Comprehensive Evaluation screening tool).
* Obtained informed consent.
* Males or females of working age, between the ages of 18 and 55.
* Medically stable with physician approval to participate
* Ability to comprehend and communicate in English at a 6th grade level
* Executive dysfunction as identified by Frontal Systems Rating Scale (FrSBe) and/or other study assessments
Exclusion Criteria:
* Unable to provide informed consent and no proxy available.
* Severe impairment of language or day- to-day memory that would preclude participation in a verbally-based therapy.
* Life expectancy of less than 36 months.
* Severe multiple trauma (as judged by the attending physicians and/or investigators that is too severe to participate in this study) such as:
* severe burns
* serious organ damage
* amputations
* multiple fractures
* History of substance abuse severe enough to cause neurologic damage, pre-morbid history of neurologic disease (e.g., stroke).
* Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness as determined by medical history.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT01816061
Study Brief:
Protocol Section:
NCT01816061