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

This study has been completed.
Sponsor:
Collaborator:
City Hospital №41, Ekaterinburg, Russia
Information provided by (Responsible Party):
Diana Vikulova, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier:
NCT01467908
First received: November 7, 2011
Last updated: February 12, 2013
Last verified: February 2013
History of Changes

November 7, 2011
February 12, 2013
June 2011
February 2012   (final data collection date for primary outcome measure)
MEP(motor evoked potential) parameter: latency [ Time Frame: within the first minute after a verbal command ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01467908 on ClinicalTrials.gov Archive Site
  • MEP(motor evoked potential) parameter: amplitude [ Time Frame: within the first minute after a verbal command ] [ Designated as safety issue: Yes ]
  • MEP(motor evoked potential) parameter: motor threshold [ Time Frame: within the first minute after a verbal command ] [ Designated as safety issue: Yes ]
  • conscious state [ Time Frame: within the first 6 months after NBS mapping ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Vegetative State
  • Stroke
  • Brain Injury
Device: Navigated transcranial magnetic brain stimulation
Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.
Experimental: Vegetative state
Patients with the diagnosis of the vegetative state
Intervention: Device: Navigated transcranial magnetic brain stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosed vegetative state
  • age 20-85

Exclusion Criteria:

  • oncological history
  • cardiac pacemakers and other metal implants
  • Modified Ashford Scale scores 3 and more
  • predisposing disease with motor neurologic impairment
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01467908
C-fMRI-NBS
Yes
Diana Vikulova, Clinical Institute of the Brain, Russia
Clinical Institute of the Brain, Russia
City Hospital №41, Ekaterinburg, Russia
Principal Investigator: Andrey A Belkin, Prof., MD, Phd Clinical Institute of Brain, Ural State Medical Academy
Clinical Institute of the Brain, Russia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP