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| ID | Type | Description | Link |
|---|---|---|---|
| 288/08 | Other Grant/Funding Number | Regional research funding |
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The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain stimulation | Experimental | Brain stimulation will consist of 4 types of intervention:
Stimulations will be counterbalanced between patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Device | 2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EEG coherence analysis | EEG will be filtered between 0.5 and 30Hz by elliptic filters. Fast Fourier Transformation will be performed on 2 sec-epochs. For each stimulation site, coherence values will be estimated within four frequency bands: Delta (0.5-3.5 Hz), Theta (4-7.5 Hz), Alpha (8-12.5 Hz), and Beta (13-30 Hz). Each coherence map will be proportionally thresholded, preserving 50% of the strongest coherence values, to produce a weighted adjacency matrix. The estimated functional connectivity patterns will be characterized by means of two global network metrics derived from graph theory: modularity and global efficiency. Modularity measures how the network is organized into modules with high level clustering. Global efficiency measures how efficient the network is in exchanging information at the global level. | Change from baseline EEG coherence at the end of brain stimulation (two weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Rating Scale | Change from baseline DRS scale at the end of brain stimulation (two weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Western Neuro Sensory Stimulation Profile (WNSSP) | This scale is developed to assess cognitive function in severely impaired head-injured adults and to monitor and predict change in slow-to-recover patients. | Change from baseline WNSSP scale at the end of brain stimulation (two weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Piccione, MD | San Camillo Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Camillo Foundation | Venice | Venice | 30126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22624587 | Background | Giacino J, Fins JJ, Machado A, Schiff ND. Central thalamic deep brain stimulation to promote recovery from chronic posttraumatic minimally conscious state: challenges and opportunities. Neuromodulation. 2012 Jul;15(4):339-49. doi: 10.1111/j.1525-1403.2012.00458.x. Epub 2012 May 24. | |
| 20647501 | Result | Piccione F, Cavinato M, Manganotti P, Formaggio E, Storti SF, Battistin L, Cagnin A, Tonin P, Dam M. Behavioral and neurophysiological effects of repetitive transcranial magnetic stimulation on the minimally conscious state: a case study. Neurorehabil Neural Repair. 2011 Jan;25(1):98-102. doi: 10.1177/1545968310369802. Epub 2010 Jul 20. |
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| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Frequency of stimulation: 10Hz. Interstimulus interval: 1 min. Number of stimuli per session: 300. Number of sessions per week: 4 Total number of stimuli: 1.200 |
|
| Transcranial Direct Current Stimulation (SHAM) | Device | The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off. |
|
| Repetitive Transcranial Magnetic Stimulation (SHAM) | Device | The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off. |
|
| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D055909 | Magnetic Field Therapy |
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