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Completed

NCT Number: NCT01467908

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.

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Key information

Conditions

Vegetative State Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Craniocerebral Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Stroke Trauma, Nervous System Unconsciousness Vascular Diseases Wounds and Injuries

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Institute of Brain

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigated transcranial magnetic brain stimulation

Device

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

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

Sponsors and collaborators

Lead sponsor

Clinical Institute of the Brain, Russia

Other

Collaborators

  • City Hospital No 41, Ekaterinburg, Russia

Registry information

Acronym: C-fMRI-NBS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2011
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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