Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

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

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

Study Overview

• Status: Completed
• Conditions: Minimally Conscious State; TBI
• Intervention / Treatment: Device: real-tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy
    • Ferrara University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coma Recovery Scale Revised (CRS-R)	behavioural scale (visual, auditory, motor, verbal, communication, arousal)	Change measures (weeks: -2,0,1,2,4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
single-pulse transcranial magnetic stimulation (TMS)	cortical excitability measures	Change measures (weeks: -2,0,1,2,4)
functional near infrared spectroscopy (fNIRS)	cerebral perfusion	Change measures (weeks: -2,0,1,2,4)
electroencephalography (EEG)	To assess if, after tDCS administration, MCS patients could show: electroencephalographic pattern modifications	Change measures (weeks: -2,0,1,2,4)
Circulating Biomarkers	blood biomarker levels modifications	Change measures (weeks: -2,0,1,2,4)

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: tDCS; Minimally Conscious State
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Damage, Chronic; Unconsciousness; Consciousness Disorders; Persistent Vegetative State
• Other Study ID Numbers: Regionale WP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO