search
Back to results

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

Primary Purpose

Vegetative State, Stroke, Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Navigated transcranial magnetic brain stimulation
Sponsored by
Clinical Institute of the Brain, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vegetative State focused on measuring Diagnosed vegetative state after stroke or traumatic brain injury

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Institute of Brain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vegetative state

Arm Description

Patients with the diagnosis of the vegetative state

Outcomes

Primary Outcome Measures

MEP(motor evoked potential) parameter: latency

Secondary Outcome Measures

MEP(motor evoked potential) parameter: amplitude
MEP(motor evoked potential) parameter: motor threshold
conscious state

Full Information

First Posted
November 7, 2011
Last Updated
February 12, 2013
Sponsor
Clinical Institute of the Brain, Russia
Collaborators
City Hospital No 41, Ekaterinburg, Russia
search

1. Study Identification

Unique Protocol Identification Number
NCT01467908
Brief Title
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
Acronym
C-fMRI-NBS
Official Title
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Institute of the Brain, Russia
Collaborators
City Hospital No 41, Ekaterinburg, Russia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegetative State, Stroke, Brain Injury
Keywords
Diagnosed vegetative state after stroke or traumatic brain injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegetative state
Arm Type
Experimental
Arm Description
Patients with the diagnosis of the vegetative state
Intervention Type
Device
Intervention Name(s)
Navigated transcranial magnetic brain stimulation
Intervention Description
Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.
Primary Outcome Measure Information:
Title
MEP(motor evoked potential) parameter: latency
Time Frame
within the first minute after a verbal command
Secondary Outcome Measure Information:
Title
MEP(motor evoked potential) parameter: amplitude
Time Frame
within the first minute after a verbal command
Title
MEP(motor evoked potential) parameter: motor threshold
Time Frame
within the first minute after a verbal command
Title
conscious state
Time Frame
within the first 6 months after NBS mapping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey A Belkin, Prof., MD, Phd
Organizational Affiliation
Clinical Institute of Brain, Ural State Medical Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Institute of Brain
City
Ekaterinburg
State/Province
Sverdlovsk region
ZIP/Postal Code
620102
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.neuro-ural.ru/
Description
Clinical Institute of Brain. Official web-site.
URL
http://www.nexstim.com/
Description
Nexstim develops, manufactures and markets Navigated Brain Stimulation devices for clinical use and scientific research.

Learn more about this trial

Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

We'll reach out to this number within 24 hrs