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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT02312635
Eligibility Criteria:
Inclusion Criteria:
* non-penetrating msTBI (intake or post-resuscitation GCS score between 3 and 12)
* 11 to 18 years of age
* between 12 and 24 months post-injury
* working memory index (WMI) standard score below 90 or evidence of at least a 10 point discrepancy between estimated IQ and WMI
* normal visual acuity or vision corrected with contact lenses/eyeglasses
* English skills sufficient to understand instructions and be familiar with common words (the neuropsychological tests used in this study presume competence in English).
Exclusion Criteria:
* tumor or severe seizures
* motor deficits that prevent the subject from being examined in an MR scanner (e.g. spasms)
* history of psychosis,
* ADHD
* Tourette's Disorder
* learning disability
* mental retardation, autism or substance abuse. The latter conditions are associated with cognitive impairments that might overlap with those caused by TBI.
* participants with any metal implants that prevent them from safely undergoing an MRI scan are excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
18 Years
Study:
NCT02312635
Study Brief:
Protocol Section:
NCT02312635