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The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that:
Design: Prospective controlled non-randomized study. Materials and methods: 30 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (awake patients vs patients with disorders of consciousness vs control persons) and intra-individually factors as 1) interstimulus intervals for transcranial magnetic stimulation and clinical scores (RLAS vs FIM vs EFA).
Significance level is set to 0.05 for all effect parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients with severe brain injury, awake, but have cognitive problems |
|
| 2 | Experimental | Patients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state) |
|
| 3 | Experimental | Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Afferent Inhibition | Within one week after clinical assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Short Intracortical Inhibition | Within one week after clinical assessment | |
| Intracortical Facilitation | Within one week after clinical assessment | |
| Motor threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natallia Lapitskaya, MD | Contact | 004587623573 | neunla@sc.aaa.dk | |
| Lena Bjorn, secretary | Contact | 0045 8762 3562 | neuleb@sc.aaa.dk |
| Name | Affiliation | Role |
|---|---|---|
| Natallia Lapitskaya, MD | Hammel Neurorehabilitation and Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammel Neurorehabilitation and Research Centre | Recruiting | Hammel | 8450 | Denmark |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D020925 | Hypoxia-Ischemia, Brain |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
|
| Within one week after clinical assessment |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002545 | Brain Ischemia |
| D002534 | Hypoxia, Brain |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |