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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05115656
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of moderate to severe TBI through medical records or interview, based on the Glasgow Coma Scale (GCS) and the definition adopted by the TBI Model Systems National Database (TBIMS NDB), where one of the following criteria must be met:
* Post traumatic amnesia \> 24 hours
* Trauma related intracranial neuroimaging abnormalities
* Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication)
* GCS in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication);
2. At least 12 months post injury
3. Presence of a deficit in sustained attention as measured by the Attention-Related Cognitive Errors Scale (ARCES) \[69\] score greater than 3.5 or presence of a deficit in sustained attention as measured by the sustained attention to response task (SART) \[64\]. Impairment will be defined as having omissions or the reaction time variability scores, two measures of "inattentiveness," one standard deviation above the normative mean.
4. Willingness and ability to participate in all testing and the 10-week intervention and daily home activities/exercises.
5. Medically stable and no plan for major change in medications for at least 6 months or for the duration of the study
6. Have sufficient language functioning to participate in an intervention conducted in English
7. Average memory functioning to be able to benefit from a progression of treatment (as measured by total learning trials on the California Verbal Learning Test-II within 2 standard deviations of the mean)
General Exclusion Criteria:
1. Severe cognitive impairment as defined by a Mini-Mental State Examination score \< 18.
2. Any previous neurological injury or illness in addition to the documented TBI (e.g. epilepsy, MS).
3. Active substance abuse
4. Acquired brain injury of nontraumatic origin
5. Be enrolled or currently enrolled in another research study that is likely to affect participation in this research study
6. Significant psychiatric history (e.g. schizophrenia, bipolar disorder) due to the potential influence of such disorders on cognitive functioning (because of the prevalence of depression/anxiety in the TBI population, subjects will not be excluded based on a history of depression/anxiety; rather, these will be controlled by including measures of depression/anxiety as covariates in group-level analyses)
7. Had previously participated in regular mindfulness based activities such as meditation and yoga.
MRI-Specific Exclusion Criteria:
1. Being pregnant or planning to become pregnant
2. Have had a penetrating TBI
3. Left handed (to control for hand dominance effect on neuroimaging)
4. Focal injury if the injury necessitated neurosurgical intervention and/or caused gross derangement of neuroanatomy (Given that TBI is most often represented by mixed pathophysiology and diffuse axonal injury is nearly universal findings, focal injury will not be a systematic exclusionary criteria).
5. For all study participants, additional exclusionary criteria associated with MRI will be discussed and enforced. This includes, conditions contraindicated for MRI (implanted metallic devices-aneurysm clips, pacemakers, claustrophobia for subject safety), surgical hardware in the head or cervical spine will also be excluded due to potential for severe image artifacts. We will be using the RONIC MRI screening form for this purpose.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05115656
Study Brief:
Protocol Section:
NCT05115656