Cortical Excitability in Patients With Severe Brain Injury
1 other identifier
interventional
45
1 country
1
Brief Summary
The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that:
- 1.There is a continuous decrease in intracortical inhibition from healthy subjects to awake patients with severe brain injury, and to patients with impaired consciousness.
- 2.Decreased intracortical inhibition correlate with the degree of impairment assessed with the clinical scores in patients with severe brain injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 11, 2008
November 1, 2008
8 months
November 10, 2008
November 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short Afferent Inhibition
Within one week after clinical assessment
Secondary Outcomes (3)
Short Intracortical Inhibition
Within one week after clinical assessment
Intracortical Facilitation
Within one week after clinical assessment
Motor threshold
Within one week after clinical assessment
Study Arms (3)
1
EXPERIMENTALPatients with severe brain injury, awake, but have cognitive problems
2
EXPERIMENTALPatients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state)
3
EXPERIMENTALHealthy volunteers
Interventions
Transcranial magnetic stimulation (TMS) using paired-pulse technique at different interstimulus intervals (ISIs) allows the study of the excitatory and inhibitory system of human motor cortex non-invasively. Motor evoked potentials (MEP) will be recorded, and stored on a VikingSelect (Viasys Healthcare, USA). Two magnetic stimulators (Magstim 200, The Magstim Company Ltd, U.K.) connected through a Bistim and a Magstim figure-of-eight coil will be used for TMS.
Eligibility Criteria
You may qualify if:
- severe brain injury (Glasgow Coma Scale score (GCS) less than 8 on admission to the acute hospital);
- stable vital functions;
- age over 18 years old;
- informed content from patient/relatives/legal guardian.
You may not qualify if:
- other neurological diseases than brain injury;
- pregnancy;
- TMS contraindications (epilepsy, metallic implantants: pacemaker or medicine pump, ferromagnetic or electronically operated stapedial implants, haemostatic clips, metallic splinters in the orbit).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammel Neurorehabilitation and Research Centre
Hammel, 8450, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natallia Lapitskaya, MD
Hammel Neurorehabilitation and Research Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 11, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2009
Study Completion
May 1, 2009
Last Updated
November 11, 2008
Record last verified: 2008-11