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Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

Primary Purpose

Minimally Conscious State, TBI

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
real-tDCS
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Minimally Conscious State focused on measuring Minimally Conscious State, tDCS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ferrara University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

real-tDCS

Arm Description

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).

Outcomes

Primary Outcome Measures

Coma Recovery Scale Revised (CRS-R)
behavioural scale (visual, auditory, motor, verbal, communication, arousal)

Secondary Outcome Measures

single-pulse transcranial magnetic stimulation (TMS)
cortical excitability measures
functional near infrared spectroscopy (fNIRS)
cerebral perfusion
electroencephalography (EEG)
To assess if, after tDCS administration, MCS patients could show: electroencephalographic pattern modifications
Circulating Biomarkers
blood biomarker levels modifications

Full Information

First Posted
January 16, 2014
Last Updated
February 2, 2017
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT02288533
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimally Conscious State, TBI
Keywords
Minimally Conscious State, tDCS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real-tDCS
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
real-tDCS
Intervention Description
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 Outcome Measure Information:
Title
Coma Recovery Scale Revised (CRS-R)
Description
behavioural scale (visual, auditory, motor, verbal, communication, arousal)
Time Frame
Change measures (weeks: -2,0,1,2,4)
Secondary Outcome Measure Information:
Title
single-pulse transcranial magnetic stimulation (TMS)
Description
cortical excitability measures
Time Frame
Change measures (weeks: -2,0,1,2,4)
Title
functional near infrared spectroscopy (fNIRS)
Description
cerebral perfusion
Time Frame
Change measures (weeks: -2,0,1,2,4)
Title
electroencephalography (EEG)
Description
To assess if, after tDCS administration, MCS patients could show: electroencephalographic pattern modifications
Time Frame
Change measures (weeks: -2,0,1,2,4)
Title
Circulating Biomarkers
Description
blood biomarker levels modifications
Time Frame
Change measures (weeks: -2,0,1,2,4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD
Organizational Affiliation
Ferrara Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

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