Navigated Brain Stimulation in Diagnosis of Minimally Conscious State (C-fMRI-NBS)

This study has been completed.
Sponsor:
Collaborator:
City Hospital №41, Ekaterinburg, Russia
Information provided by (Responsible Party):
Diana Vikulova, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier:
NCT01467908
First received: November 7, 2011
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Vegetative State
Stroke
Brain Injury
Device: Navigated transcranial magnetic brain stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Resource links provided by NLM:


Further study details as provided by Clinical Institute of the Brain, Russia:

Primary Outcome Measures:
  • MEP(motor evoked potential) parameter: latency [ Time Frame: within the first minute after a verbal command ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MEP(motor evoked potential) parameter: amplitude [ Time Frame: within the first minute after a verbal command ] [ Designated as safety issue: Yes ]
  • MEP(motor evoked potential) parameter: motor threshold [ Time Frame: within the first minute after a verbal command ] [ Designated as safety issue: Yes ]
  • conscious state [ Time Frame: within the first 6 months after NBS mapping ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vegetative state
Patients with the diagnosis of the vegetative state
Device: Navigated transcranial magnetic brain stimulation
Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467908

Locations
Russian Federation
Clinical Institute of Brain
Ekaterinburg, Sverdlovsk region, Russian Federation, 620102
Sponsors and Collaborators
Clinical Institute of the Brain, Russia
City Hospital №41, Ekaterinburg, Russia
Investigators
Principal Investigator: Andrey A Belkin, Prof., MD, Phd Clinical Institute of Brain, Ural State Medical Academy
  More Information

Additional Information:
No publications provided

Responsible Party: Diana Vikulova, MD, neurologist, investigator, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier: NCT01467908     History of Changes
Other Study ID Numbers: C-fMRI-NBS
Study First Received: November 7, 2011
Last Updated: February 12, 2013
Health Authority: Ural State Medical Academy: Russia

Keywords provided by Clinical Institute of the Brain, Russia:
Diagnosed vegetative state after stroke or traumatic brain injury

Additional relevant MeSH terms:
Stroke
Brain Injuries
Persistent Vegetative State
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014