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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03799458
Eligibility Criteria:
Inclusion Criteria:
1. are US Veteran or Active Duty Military personnel aged 18-59,
2. have suffered a mild TBI (alteration in neurological functioning \< 24 hours, loss of consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA));
3. were injured between 3 months and 15 years ago;
4. have post-traumatic sensory symptoms as evidenced by endorsing at least 2 out of 12 sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of "3" or higher,
5. are fluent in English,
6. have been on stable doses of any psychotropic medications for the past 2 months.
7. The imaging-only group will have the same inclusion and exclusion criteria except they will not have had a head injury.
Exclusion Criteria:
1. any history of moderate or severe TBI;
2. a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
3. history of psychosis, so as to reduce risk of psychiatric decompensation;
4. history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition and plasticity;
5. any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current;
6. presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device malfunction;
7. recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study;
8. any condition that would prevent the subject from completing the protocol; 9) appointment of a legal representative, as assessed via direct inquiry of the subject and a designated trusted other, to avoid coercion of a vulnerable population;
10\) any significant blindness, to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT03799458
Study Brief:
Protocol Section:
NCT03799458