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

• Sponsor: Clinical Institute of the Brain, Russia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01467908
• Collaborator: City Hospital No 41, Ekaterinburg, Russia (Other)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vegetative State; Stroke; Brain Injury	Device: Navigated transcranial magnetic brain stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. MEP(motor evoked potential) parameter: latency [within the first minute after a verbal command]

Secondary Outcome Measures

1. MEP(motor evoked potential) parameter: amplitude [within the first minute after a verbal command]

2. MEP(motor evoked potential) parameter: motor threshold [within the first minute after a verbal command]

3. conscious state [within the first 6 months after NBS mapping]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Institute of Brain	Ekaterinburg	Sverdlovsk region	Russian Federation	620102

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Andrey A Belkin, Prof., MD, Phd, Clinical Institute of Brain, Ural State Medical Academy

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Diana Vikulova, MD, neurologist, investigator, Clinical Institute of the Brain, Russia
• ClinicalTrials.gov Identifier: NCT01467908
• Other Study ID Numbers: C-fMRI-NBS
• First Posted: Nov 9, 2011
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Diana Vikulova, MD, neurologist, investigator, Clinical Institute of the Brain, Russia: Diagnosed vegetative state after stroke or traumatic brain injury
• Additional relevant MeSH terms: Brain Injuries; Persistent Vegetative State

Study Results

No Results Posted as of Feb 15, 2013