Transcranial Brain Stimulation in Vegetative State Patients
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|ClinicalTrials.gov Identifier: NCT01820923|
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Vegetative State Minimally Conscious State||Device: Transcranial direct current stimulation (tDCS) Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Transcranial Direct Current Stimulation (SHAM) Device: Repetitive Transcranial Magnetic Stimulation (SHAM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Brain stimulation
Brain stimulation will consist of 4 types of intervention:
Stimulations will be counterbalanced between patients.
Device: Transcranial direct current stimulation (tDCS)
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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
Device: Transcranial Direct Current Stimulation (SHAM)
The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
Device: Repetitive Transcranial Magnetic Stimulation (SHAM)
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
- EEG coherence analysis [ Time Frame: Change from baseline EEG coherence at the end of brain stimulation (two weeks) ]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.
- Disability Rating Scale [ Time Frame: Change from baseline DRS scale at the end of brain stimulation (two weeks) ]
- Western Neuro Sensory Stimulation Profile (WNSSP) [ Time Frame: Change from baseline WNSSP scale at the end of brain stimulation (two weeks) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820923
|IRCCS San Camillo Foundation|
|Venice, Italy, 30126|
|Study Director:||Francesco Piccione, MD||San Camillo Foundation|