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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07485361
Eligibility Criteria:
Inclusion Criteria:
Healthy Control Participants:
* Age 18 years or older
* Proficient in English language
* Intact cognition
* Montreal Cognitive Assessment (MoCA) score \> 26
DoC Patients:
* Age 18 years or older
* Proficient in English language
* Surrogate decision maker available
* Admission to the intensive care unit within 28 days
* Documented Glasgow Coma Scale (GCS) score
* Auditory Function subscale score ≥1 on the Coma Recovery Scale-Revised (CRS-R)
Exclusion Criteria:
Healthy Control Participants:
* Known baseline hearing impairment without available hearing aids
* Neurological or psychiatric history
DoC Patients:
* Known baseline hearing impairment without available hearing aids
* Inability to obtain informed consent
* Extensive bilateral frontal injury on available imaging (CT/MRI)
* Patients who have undergone craniectomy surgery
* IV sedation in the past 24 hours
* Absent auditory startle response (\<1 from Auditory Function subscale score of CRS-R)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07485361
Study Brief:
Protocol Section:
NCT07485361