Vagal Nerve Stimulation in Coma Patients

NCT ID: NCT02591069

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-01-31

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.

Conditions

Chronic Consciousness Disorders; Vegetative State; Minimally Conscious State; Akinetic Mutism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All patients will undergo the same procedure

Group Type: EXPERIMENTAL

stimulation device

Intervention Type: DEVICE

All patients included in the study will undergo baseline assessment of all measures before surgery (implantation of a vagus nerve stimulation device). A second baseline assessment will take place after surgery, before the beginning of the stimulation. Stimulation intensity will start at 0.25mA and increase progressively by 0.25mA each week until reaching 1mA. Then, intensity will be set at 1.5mA (recommended by manufacturer) and will stay to this level until the end of the trial. Experimenters will keep the right to modify these parameters depending on patients' reaction to the treatment.

Interventions

stimulation device

All patients included in the study will undergo baseline assessment of all measures before surgery (implantation of a vagus nerve stimulation device). A second baseline assessment will take place after surgery, before the beginning of the stimulation. Stimulation intensity will start at 0.25mA and increase progressively by 0.25mA each week until reaching 1mA. Then, intensity will be set at 1.5mA (recommended by manufacturer) and will stay to this level until the end of the trial. Experimenters will keep the right to modify these parameters depending on patients' reaction to the treatment.

Intervention Type: 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Luauté, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Neurologique de Lyon Pierre Wertheimer

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Angela Sirigu, PhD

Role: CONTACT

sirigu@isc.cnrs.fr

04 37 91 12 31

Jacques Luauté, Pr

Role: CONTACT

jacques.luaute@chu-lyon.fr

04 72 35 78 95

Facility Contacts

Jacques Luauté, MD

Role: primary

jacques.luaute@chu-lyon.fr

4 72 35 78 95 ext. 0033

Other Identifiers

2014-A00125-42

Identifier Type: OTHER

Identifier Source: secondary_id

2013-833

Identifier Type: -

Identifier Source: org_study_id