Vagal Nerve Stimulation in Coma Patients

Last updated: November 21, 2019
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Speech Disorders

Treatment

N/A

Clinical Study ID

NCT02591069
2013-833
2014-A00125-42
  • Ages 18-60
  • All Genders

Study 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

Inclusion Criteria:

  • Aged between 18 and 60 years old

  • Patients with history of cranial trauma, cerebrovascular accident, or other eventleading to cerebral anoxia, suffering of chronic alteration of consciousness (Vegetative State, Minimally Conscious State, akinetic mutism). The diagnostic will bebased 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

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 forthe 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)

Study Design

Total Participants: 4
Study Start date:
October 01, 2015
Estimated Completion Date:
January 31, 2021

Connect with a study center

  • Hôpital Neurologique de Lyon Pierre Wertheimer

    Bron, 69500
    France

    Active - Recruiting

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