Vegetative StateC-fMRI-NBSNCT01467908
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
A study testing Navigated transcranial magnetic brain stimulation in people with Vegetative State and Stroke, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Vegetative State, Stroke, Brain Injury
- What is being tested?
- Navigated transcranial magnetic brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed vegetative state
- age 20-85
Who cannot join
- oncological history
- cardiac pacemakers and other metal implants
- Modified Ashford Scale scores 3 and more
- predisposing disease with motor neurologic impairment
Trial locations and contacts
1 site in 1 country.
Russia1 site
Clinical Institute of Brain
Yekaterinburg, Sverdlovsk Oblast, 620102
About this study
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
- Being tested
- Navigated transcranial magnetic brain stimulation
- Keywords
- Diagnosed vegetative state after stroke or traumatic brain injury
- Medical subject headings
- Persistent Vegetative State, Stroke, Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated transcranial magnetic brain stimulationDevice
Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.
| Study group | Role | What they receive |
|---|---|---|
| Vegetative state | Experimental | Patients with the diagnosis of the vegetative state Receives: Device: Navigated transcranial magnetic brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP(motor evoked potential) parameter: latency
Measured: within the first minute after a verbal command
Secondary outcomes (3)
MEP(motor evoked potential) parameter: amplitude
Measured: within the first minute after a verbal command
MEP(motor evoked potential) parameter: motor threshold
Measured: within the first minute after a verbal command
conscious state
Measured: within the first 6 months after NBS mapping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vegetative StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Institute of the Brain, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- City Hospital No 41, Ekaterinburg, Russia
- Responsible party
- Principal investigator, Diana Vikulova, Clinical Institute of the Brain, Russia
- Investigators
- Andrey A Belkin, Prof., MD, Phd, Principal investigator, Clinical Institute of Brain, Ural State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467908
- Sponsor's protocol ID
- C-fMRI-NBS
- Acronym
- C-fMRI-NBS
- Status last verified
- Feb 2013
- First submitted
- 7 Nov 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
- ClinicalTrials.gov ID
- NCT01467908
- Acronym / sponsor ID
- C-fMRI-NBS / C-fMRI-NBS
- Conditions
- Vegetative State, Stroke, Brain Injury
- Keywords
- Diagnosed vegetative state after stroke or traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Clinical Institute of the Brain, RussiaUniversity, hospital or other
- Collaborators
- City Hospital No 41, Ekaterinburg, Russia
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vegetative state | Experimental | Device: Navigated transcranial magnetic brain stimulationPatients with the diagnosis of the vegetative state |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed vegetative state
- age 20-85
Key exclusion criteria (4 listed)
- oncological history
- cardiac pacemakers and other metal implants
- Modified Ashford Scale scores 3 and more
- predisposing disease with motor neurologic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigated transcranial magnetic brain stimulationStandard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland. | Device | Vegetative state |
Primary outcome
MEP(motor evoked potential) parameter: latency
Time frame: within the first minute after a verbal command
3 secondary outcomes
MEP(motor evoked potential) parameter: amplitude
Time frame: within the first minute after a verbal command
MEP(motor evoked potential) parameter: motor threshold
Time frame: within the first minute after a verbal command
conscious state
Time frame: within the first 6 months after NBS mapping
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Clinical Institute of Brain. Official web-site.Link provided by the sponsor.
- Nexstim develops, manufactures and markets Navigated Brain Stimulation devices for clinical use and scientific research.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey A Belkin, Prof., MD, Phd principal investigator
Clinical Institute of Brain, Ural State Medical Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigated transcranial magnetic brain stimulation in people with Vegetative State and Stroke, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEP(motor evoked potential) parameter: latency (time frame: within the first minute after a verbal command). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.