Informations générales (source: ClinicalTrials.gov)
Vagus Nerve Stimulation in Patients With Chronic Consciousness Disorders (SNV)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
octobre 2015
janvier 2021
29 juin 2024
Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which
often occur following traumatic brain injury or ischemia. These alterations result most
of the time in patients' loss of autonomy and require long years of special care. No
efficient therapy to improve patients' consciousness has been found so far. Investigators
propose to use vagal nerve stimulation (VNS) to restore cortical activity and patients'
embodied self. The investigators' main hypothesis is that VNS will reestablish the
thalamo-cortical connectivity leading to an improvement of the consciousness state. To
test this hypothesis, investigators will use behavioral measures as well as fMRI, PET
scan and EEG to assess brain activity. Patients will be evaluated before and during eight
months following implantation of the stimulation device.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Neurologique de Lyon Pierre Wertheimer - 69500 - Bron - France | Jacques Luauté, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)