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

February 12, 2013 updated by: Diana Vikulova, Clinical Institute of the Brain, Russia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Sverdlovsk region
      • Ekaterinburg, Sverdlovsk region, Russian Federation, 620102
        • Clinical Institute of Brain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MEP(motor evoked potential) parameter: latency
Time Frame: within the first minute after a verbal command
within the first minute after a verbal command

Secondary Outcome Measures

Outcome Measure
Time Frame
MEP(motor evoked potential) parameter: amplitude
Time Frame: within the first minute after a verbal command
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
within the first minute after a verbal command
conscious state
Time Frame: within the first 6 months after NBS mapping
within the first 6 months after NBS mapping

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Institute of the Brain, Russia

Collaborators

City Hospital No 41, Ekaterinburg, Russia

Investigators

  • Principal Investigator: Andrey A Belkin, Prof., MD, Phd, Clinical Institute of Brain, Ural State Medical Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-fMRI-NBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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