Clinical trial NCT02591069: Vagal Nerve Stimulation in Coma Patients
Official title: Vagus Nerve Stimulation in Patients With Chronic Consciousness Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Consciousness Disorders
Vegetative State
Minimally Conscious State
Akinetic Mutism
Keywords: Vagus nerve stimulation
vegetative state
minimally conscious state
akinetic mutism
consciousness
connectivity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


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)

Primary outcomes:
measure: Change over time of clinical scores on the Coma Recovery Scale - Revised
timeFrame: First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation; then once a month for 6 months.
Secondary outcomes:
measure: Evaluation of brain activity changes using EEG
timeFrame: First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.
measure: MRI (anisotropy and fibers density) evaluation of anatomo-connectivity changes
timeFrame: First assessment one week before implantation second assessment 3 weeks after implantation and then one, three and six months after the onset of stimulation.
measure: fMRI evaluation of bold signal resting state activity and functional connectivity changes
timeFrame: Firsts First assessment one week before implantation second assessment 3 weeks after implantation,, and then one, three and six months after the onset of stimulation.
measure: PET scan evaluation of brain metabolism (Glucose consumption) changes
timeFrame: One baseline assessment one week before stimulation and a second one after 3 months of stimulation.
measure: Monitoring heart rate variability
timeFrame: First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.
measure: : Monitoring changes of serum free serotonin concentration
timeFrame: First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.
measure: Monitoring changes of thermal reaction to emotional stimuli
timeFrame: First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique de Lyon Pierre Wertheimer
Study officials:
affiliation: Hospices Civils de Lyon
name: Jacques Luauté, Pr
role: PRINCIPAL_INVESTIGATOR
References: