Vagal Nerve Stimulation in Coma Patients (SNV)

Civil Hospices of Lyon

Status

Unknown

Conditions

Vegetative State

Minimally Conscious State

Akinetic Mutism

Chronic Consciousness Disorders

Treatments

Device: stimulation device

Study type

Interventional

Funder types

Other

Identifiers

NCT02591069

2013-833

2014-A00125-42 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

4 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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)