Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Stroke Clinical Trial

— C-fMRI-NBS  

Official title:

Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467908
• Other study ID #: C-fMRI-NBS
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: February 12, 2013
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Clinical Institute of the Brain, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ural State Medical Academy: Russia
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Persistent Vegetative State
• Stroke
• Vegetative State

Intervention

Device:
• Navigated transcranial magnetic brain stimulation
Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.

Locations

Country	Name	City	State
Russian Federation	Clinical Institute of Brain	Ekaterinburg	Sverdlovsk region

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Institute of the Brain, Russia	City Hospital No 41, Ekaterinburg, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEP(motor evoked potential) parameter: latency		within the first minute after a verbal command	Yes
Secondary	MEP(motor evoked potential) parameter: amplitude		within the first minute after a verbal command	Yes
Secondary	MEP(motor evoked potential) parameter: motor threshold		within the first minute after a verbal command	Yes
Secondary	conscious state		within the first 6 months after NBS mapping	Yes

External Links

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