Clinical trial NCT02288533: Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders
Official title: Transcranial Direct Current Stimulation (tDCS) Effects in Patients With Chronic Consciousness Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimally Conscious State
TBI
Keywords: Minimally Conscious State
tDCS
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Chronic consciousness disorders have high level of impact on public health and its costs.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* males and females aged \>18 years old and \<70 years old
* diagnosis of disorders of consciousness classified as MCS according to criteria of American Academy of Neurology1.
* traumatic etiology (\>12 months after the acute injury)

Exclusion Criteria:

* contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants, history of seizures, metal in the head, implanted brain medical devices.
* contraindications to tDCS such as metal in the head, implanted brain medical devices.

Primary outcomes:
measure: Coma Recovery Scale Revised (CRS-R)
timeFrame: Change measures (weeks: -2,0,1,2,4)
Secondary outcomes:
measure: single-pulse transcranial magnetic stimulation (TMS)
timeFrame: Change measures (weeks: -2,0,1,2,4)
measure: functional near infrared spectroscopy (fNIRS)
timeFrame: Change measures (weeks: -2,0,1,2,4)
measure: electroencephalography (EEG)
timeFrame: Change measures (weeks: -2,0,1,2,4)
measure: Circulating Biomarkers
timeFrame: Change measures (weeks: -2,0,1,2,4)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD
role: PRINCIPAL_INVESTIGATOR
References: