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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT02591069
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 60 years old
* Patients with history of cranial trauma, cerebrovascular accident, or other event leading to cerebral anoxia, suffering of chronic alteration of consciousness (Vegetative State, Minimally Conscious State, akinetic mutism). The diagnostic will be based on clinical scales
* Patients already having a neurophysiologic checkup (EEG)
* Patients breathing without invasive help, and who are in a stable medical state
* Patients with a history of disease of at least 6 months
* Patients without clinical evolution for several months
* Patients with social security
* Patients for whom a family member have signed a written consent
Exclusion Criteria:
* Patients with tracheotomy
* Pregnant women
* Intubated patients
* Patients with damaged vagus nerves
* Patients with pre existing neurological conditions other than the one responsible for the consciousness disorder
* Patients with medical complications
* Patients suffering of septic infection
* Patients with a significant dysphagia
* Patients with dyspnea or shortness of breath
* Patients with obstructive sleep apnea
* Patients with any conditions non authorized by the stimulating device manufacturer (Cyberonics)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02591069
Study Brief:
Protocol Section:
NCT02591069