Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

NCT01467908 | Completed DMC

• 1 other identifier: C-fMRI-NBS
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Vegetative State; Stroke; Brain Injury

Keywords

Diagnosed vegetative state after stroke or traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• MEP(motor evoked potential) parameter: latency

  within the first minute after a verbal command

Secondary Outcomes (3)

• MEP(motor evoked potential) parameter: amplitude

  within the first minute after a verbal command

• MEP(motor evoked potential) parameter: motor threshold

  within the first minute after a verbal command

• conscious state

  within the first 6 months after NBS mapping

Study Arms (1)

Vegetative state

EXPERIMENTAL

Patients with the diagnosis of the vegetative state

Device: Navigated transcranial magnetic brain stimulation

Interventions

Navigated transcranial magnetic brain stimulation DEVICE

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

Vegetative state

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed vegetative state
• age 20-85

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Institute of the Brain, Russia: lead
• City Hospital No 41, Ekaterinburg, Russia: collaborator

Study Sites (1)

Clinical Institute of Brain

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Location

Related Links

• Clinical Institute of Brain. Official web-site.
• Nexstim develops, manufactures and markets Navigated Brain Stimulation devices for clinical use and scientific research.

MeSH Terms

Conditions

Persistent Vegetative State; Stroke; Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrey A Belkin, Prof., MD, Phd

  Clinical Institute of Brain, Ural State Medical Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, neurologist, investigator

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

RU (1)