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Vagal Nerve Stimulation in Coma Patients

NCT02591069 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-11-25

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Jacques Luauté, Pr · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-01-31
Completion
2021-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591069 on ClinicalTrials.gov