Vagal Nerve Stimulation in Coma Patients

NCT02591069 | Unknown DMC

• 2 other identifiers: 2013-8332014-A00125-42
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Vagus nerve stimulation; vegetative state; minimally conscious state; akinetic mutism; consciousness; connectivity

Outcome Measures

Primary Outcomes (1)

• Change over time of clinical scores on the Coma Recovery Scale - Revised

  The primary outcome will be the change over time of patients' clinical state. Investigators will employ a widely used scale: Coma Recovery Scale - Revised. Patients will be evaluated by the same trained doctor. Results will be analyzed using a within subject design, each patients will be his own control. Investigators predict a progressive improvement after the onset of treatment, compared to the two pre-stimulation evaluations.

  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 (7)

• Evaluation of brain activity changes using EEG

  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.

• MRI (anisotropy and fibers density) evaluation of anatomo-connectivity changes

  First assessment one week before implantation second assessment 3 weeks after implantation and then one, three and six months after the onset of stimulation.

• fMRI evaluation of bold signal resting state activity and functional connectivity changes

  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.

• PET scan evaluation of brain metabolism (Glucose consumption) changes

  One baseline assessment one week before stimulation and a second one after 3 months of stimulation.

• Monitoring heart rate variability

  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.

Study Arms (1)

All patients will undergo the same procedure

EXPERIMENTAL

Device: stimulation device

Interventions

stimulation device 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.

All patients will undergo the same procedure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Neurologique de Lyon Pierre Wertheimer

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Persistent Vegetative State; Akinetic Mutism

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Luauté, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Sirigu, PhD

CONTACT

04 37 91 12 31; sirigu@isc.cnrs.fr

Jacques Luauté, Pr

CONTACT

04 72 35 78 95; jacques.luaute@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2021
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

FR (1)