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Completed

NCT Number: NCT02288533

Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

real-tDCS

Device

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).

Primary outcomes

  1. Coma Recovery Scale Revised (CRS-R)

    Time frame: Change measures (weeks: -2,0,1,2,4)

    behavioural scale (visual, auditory, motor, verbal, communication, arousal)

Secondary outcomes

  1. single-pulse transcranial magnetic stimulation (TMS)

    Time frame: Change measures (weeks: -2,0,1,2,4)

    cortical excitability measures

  2. functional near infrared spectroscopy (fNIRS)

    Time frame: Change measures (weeks: -2,0,1,2,4)

    cerebral perfusion

  3. electroencephalography (EEG)

    Time frame: Change measures (weeks: -2,0,1,2,4)

    To assess if, after tDCS administration, MCS patients could show: electroencephalographic pattern modifications

  4. Circulating Biomarkers

    Time frame: Change measures (weeks: -2,0,1,2,4)

    blood biomarker levels modifications

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) Effects in Patients With Chronic Consciousness Disorders

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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