Vegetative State, Minimally Conscious State
Conditions
Brief summary
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.
Interventions
DEVICETranscranial direct current stimulation (tDCS)
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
DEVICERepetitive 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
The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
Sponsors
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29. * Age between 18 and 65 years. * Time from the lesion: more than 4 months. * Stable clinical condition. * written consent fron the legal administrator of the patient.
Exclusion criteria
* Presence of epileptiform activity on EEG. * Previous history of epilepsy. * Extensive hemorrhage or ischemia. * Metallic clips or intracranial implants. * Pacemaker e Baclofen infusion. * Presence of drugs influencing arousal or awareness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG coherence analysis | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Disability Rating Scale | Change from baseline DRS scale at the end of brain stimulation (two weeks) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Western Neuro Sensory Stimulation Profile (WNSSP) | 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. |
Countries
Italy
Outcome results
None listed