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Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01467908
Acronym
C-fMRI-NBS
Enrollment
6
Registered
2011-11-09
Start date
2011-06-30
Completion date
2012-10-31
Last updated
2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Stroke, Vegetative State

Keywords

Diagnosed vegetative state after stroke or traumatic brain injury

Brief 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.

Interventions

DEVICENavigated transcranial magnetic brain stimulation

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

Sponsors

City Hospital No 41, Ekaterinburg, Russia
CollaboratorOTHER
Clinical Institute of the Brain, Russia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
MEP(motor evoked potential) parameter: latencywithin the first minute after a verbal command

Secondary

MeasureTime frame
MEP(motor evoked potential) parameter: amplitudewithin the first minute after a verbal command
MEP(motor evoked potential) parameter: motor thresholdwithin the first minute after a verbal command
conscious statewithin the first 6 months after NBS mapping

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026