CClinicalTrials.gg
CompletedNCT01467908C-fMRI-NBSUpdated Feb 15, 2013

Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

An interventional study of Navigated transcranial magnetic brain stimulation in Vegetative State, Stroke and Brain Injury, sponsored by Clinical Institute of the Brain, Russia. Completed at 1 site in Russian Federation. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Clinical Institute of the Brain, Russia · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
20 Years to 85 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Vegetative State
  • Stroke
  • Brain Injury

Keywords

  • Diagnosed vegetative state after stroke or traumatic brain injury
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 6 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Clinical Institute of the Brain, Russia is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosed vegetative state
  • age 20-85

Exclusion criteria

Exclusion Criteria:

  • oncological history
  • cardiac pacemakers and other metal implants
  • Modified Ashford Scale scores 3 and more
  • predisposing disease with motor neurologic impairment
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Vegetative state

    Patients with the diagnosis of the vegetative state

    Device: Navigated transcranial magnetic brain stimulation

Interventions

  • DeviceNavigated transcranial magnetic brain stimulation

    Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.

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What researchers measure

Primary outcomes

  1. MEP(motor evoked potential) parameter: latency

    Time frame: within the first minute after a verbal command

Secondary outcomes

  1. MEP(motor evoked potential) parameter: amplitude

    Time frame: within the first minute after a verbal command

  2. MEP(motor evoked potential) parameter: motor threshold

    Time frame: within the first minute after a verbal command

  3. conscious state

    Time frame: within the first 6 months after NBS mapping

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Study locations

1 site
  • Clinical Institute of Brain
    Ekaterinburg, Sverdlovsk region 620102, Russian Federation
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01467908
Lead sponsor
Clinical Institute of the Brain, Russia
Collaborators
City Hospital No 41, Ekaterinburg, Russia
Responsible party
Diana Vikulova (MD, neurologist, investigator, Clinical Institute of the Brain, Russia) — Principal investigator
First posted
Nov 9, 2011
Start date
Jun 2011
Primary completion
Feb 2012
Completion
Oct 2012
Last update
Feb 15, 2013

Study contacts

Andrey A Belkin, Prof., MD, Phd
principal investigator · Clinical Institute of Brain, Ural State Medical Academy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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