Navigated Brain Stimulation in Diagnosis of Minimally Conscious State "C-fMRI-NBS"

Completed

Phase N/A Results N/A

Trial Description

It has already been demonstrated that mental imagining of the complex motor act, such as limb lifting, can evoke the activation of the involved motor centres even if it doesn't result in movement due to paresis. Aim of the study: using the navigated brain stimulation system create a new diagnostic model for the differential diagnostics between the vegetative state and the minimally conscious state. If the investigators could get from patient the efferent motor response after a verbal command, his level of conscious should not be defined less than the minimally conscious state.

Conditions

Interventions

  • Navigated transcranial magnetic brain stimulation Device
    Intervention Desc: Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.
    ARM 1: Kind: Experimental
    Label: Vegetative state
    Description: Patients with the diagnosis of the vegetative state

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary MEP(motor evoked potential) parameter: latency within the first minute after a verbal command Yes
Secondary MEP(motor evoked potential) parameter: amplitude within the first minute after a verbal command Yes
Secondary MEP(motor evoked potential) parameter: motor threshold within the first minute after a verbal command Yes
Secondary conscious state within the first 6 months after NBS mapping Yes

Sponsors