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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467908
First Posted: November 9, 2011
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
City Hospital No 41, Ekaterinburg, Russia
Information provided by (Responsible Party):
Diana Vikulova, Clinical Institute of the Brain, Russia
  Purpose
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.

Condition Intervention
Vegetative State Stroke Brain Injury Device: Navigated transcranial magnetic brain stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Further study details as provided by Diana Vikulova, Clinical Institute of the Brain, Russia:

Primary Outcome Measures:
  • MEP(motor evoked potential) parameter: latency [ Time Frame: within the first minute after a verbal command ]

Secondary Outcome Measures:
  • MEP(motor evoked potential) parameter: amplitude [ Time Frame: within the first minute after a verbal command ]
  • MEP(motor evoked potential) parameter: motor threshold [ Time Frame: within the first minute after a verbal command ]
  • conscious state [ Time Frame: within the first 6 months after NBS mapping ]

Enrollment: 6
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vegetative state
Patients with the diagnosis of the vegetative state
Device: Navigated transcranial magnetic brain stimulation
Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467908


Locations
Russian Federation
Clinical Institute of Brain
Ekaterinburg, Sverdlovsk region, Russian Federation, 620102
Sponsors and Collaborators
Clinical Institute of the Brain, Russia
City Hospital No 41, Ekaterinburg, Russia
Investigators
Principal Investigator: Andrey A Belkin, Prof., MD, Phd Clinical Institute of Brain, Ural State Medical Academy
  More Information

Additional Information:
Responsible Party: Diana Vikulova, MD, neurologist, investigator, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier: NCT01467908     History of Changes
Other Study ID Numbers: C-fMRI-NBS
First Submitted: November 7, 2011
First Posted: November 9, 2011
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Diana Vikulova, Clinical Institute of the Brain, Russia:
Diagnosed vegetative state after stroke or traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Persistent Vegetative State
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms