An interventional study of real-tDCS in Minimally Conscious State and TBI, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Other
Chronic consciousness disorders have high level of impact on public health and its costs.
Consciousness disorders have high impact on society and national health system. One of these disorders is vegetative condition in which, as in coma, there isn't any self or environmental consciousness but there is alertness, whereas in minimal state of consciousness at least part of awareness is conserved.
In Emilia Romagna region about 80 people per million of inhabitants are hospitalized after cerebral damage, and after discharge about 1/5 of patients are stabilized in a consciousness disorder.
The diagnosis of these disorders is based on neurobehavioural tests, for example JFK Coma Recovery Scale Revised (CRS-R).
In these patients recovery of state of consciousness is one of the main challenges. There are very little evidences about treatment, it has been proposed the use of therapies that could modulate central nervous system activity, like specific drugs, neuroimaging and neuromodulation techniques such as transcranial magnetic stimulation and repetitive transcranial current stimulation.
A non invasive neuromodulation technique is transcranial direct current stimulation (tDCS) which can modulate cortical excitability: cathodic current reduces excitability whereas anodic current increases it.
In conclusion, tDCS is an easy technique to use, it's not invasive and it's an efficient tool for the modulation of cortical excitability that demonstrated reliable results in healthy subjects.
As the tDCS can modulate cortical excitability it is likely that the combination of this stimulation tool with transcranial magnetic stimulation for the registration of cortical excitability could give important information about cerebral damage in patients with consciousness disorders and to test new treatments. It is also likely that the modification of cortical excitability could induce neurobehavioural changes.
71 studies on the registry are indexed under Persistent Vegetative State; 13 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 45 interventional studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).
Device: real-tDCS
Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).
Coma Recovery Scale Revised (CRS-R)
behavioural scale (visual, auditory, motor, verbal, communication, arousal)
Time frame: Change measures (weeks: -2,0,1,2,4)
single-pulse transcranial magnetic stimulation (TMS)
cortical excitability measures
Time frame: Change measures (weeks: -2,0,1,2,4)
functional near infrared spectroscopy (fNIRS)
cerebral perfusion
Time frame: Change measures (weeks: -2,0,1,2,4)
electroencephalography (EEG)
To assess if, after tDCS administration, MCS patients could show: electroencephalographic pattern modifications
Time frame: Change measures (weeks: -2,0,1,2,4)
Circulating Biomarkers
blood biomarker levels modifications
Time frame: Change measures (weeks: -2,0,1,2,4)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara