Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

NCT ID: NCT02288533

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-11-30

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.

Conditions

Minimally Conscious State; TBI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

real-tDCS

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sofia Straudi, MD

Role: PRINCIPAL_INVESTIGATOR

Ferrara Rehabilitation Hospital

Locations

Ferrara University Hospital

Ferrara, Italy, Italy

Countries

Italy

Other Identifiers

Regionale WP2

Identifier Type: -

Identifier Source: org_study_id