Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

NCT ID: NCT01467908

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vegetative State Stroke Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Vegetative state

Patients with the diagnosis of the vegetative state

Group Type EXPERIMENTAL

Navigated transcranial magnetic brain stimulation

Intervention Type DEVICE

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

Interventions

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Navigated transcranial magnetic brain stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City Hospital No 41, Ekaterinburg, Russia

OTHER

Sponsor Role collaborator

Clinical Institute of the Brain, Russia

OTHER

Sponsor Role lead

Responsible Party

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Diana Vikulova

MD, neurologist, investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrey A Belkin, Prof., MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Clinical Institute of Brain, Ural State Medical Academy

Locations

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Clinical Institute of Brain

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

Countries

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Russia

Related Links

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http://www.neuro-ural.ru/

Clinical Institute of Brain. Official web-site.

http://www.nexstim.com/

Nexstim develops, manufactures and markets Navigated Brain Stimulation devices for clinical use and scientific research.

Other Identifiers

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C-fMRI-NBS

Identifier Type: -

Identifier Source: org_study_id

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