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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT02742506
Eligibility Criteria:
Brain-damaged patients :
Inclusion Criteria:
* Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
* Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
* Lack of autonomic crisis since one week minimum
* Medical condition considered stable
* Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.
Exclusion Criteria:
* Hearing Problem
* Uncontrolled Epilepsy
* Autonomic crises
* Medical unstable state
* Pregnant or likely to be (interrogation data) or breastfeeding woman
Healthy participants :
Inclusion Criteria:
* Subjects with normal hearing
* Absence of neurological disorder
* Subjects able to understand the experimental instructions
Exclusion Criteria:
* Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
* Neurological disorders
* Pregnant or likely to be (interrogation data) or breastfeeding woman
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02742506
Study Brief:
Protocol Section:
NCT02742506