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Transcranial Brain Stimulation in Vegetative State Patients

Primary Purpose

Vegetative State, Minimally Conscious State

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Transcranial Direct Current Stimulation (SHAM)
Repetitive Transcranial Magnetic Stimulation (SHAM)
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vegetative State

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29.
  • Age between 18 and 65 years.
  • Time from the lesion: more than 4 months.
  • Stable clinical condition.
  • written consent fron the legal administrator of the patient.

Exclusion Criteria:

  • Presence of epileptiform activity on EEG.
  • Previous history of epilepsy.
  • Extensive hemorrhage or ischemia.
  • Metallic clips or intracranial implants.
  • Pacemaker e Baclofen infusion.
  • Presence of drugs influencing arousal or awareness.

Sites / Locations

  • IRCCS San Camillo Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain stimulation

Arm Description

Brain stimulation will consist of 4 types of intervention: real transcranial direct current stimulation (two weeks, five days a week) a week of wash-out Sham transcranial direct current stimulation (two weeks, five days a week) two weeks of wash-out real repetitive transcranial magnetic stimulation (two weeks, four days a week) a week of wash-out Sham repetitive transcranial magnetic stimulation (two weeks, three days a week) Stimulations will be counterbalanced between patients.

Outcomes

Primary Outcome Measures

EEG coherence analysis
EEG will be filtered between 0.5 and 30Hz by elliptic filters. Fast Fourier Transformation will be performed on 2 sec-epochs. For each stimulation site, coherence values will be estimated within four frequency bands: Delta (0.5-3.5 Hz), Theta (4-7.5 Hz), Alpha (8-12.5 Hz), and Beta (13-30 Hz). Each coherence map will be proportionally thresholded, preserving 50% of the strongest coherence values, to produce a weighted adjacency matrix. The estimated functional connectivity patterns will be characterized by means of two global network metrics derived from graph theory: modularity and global efficiency. Modularity measures how the network is organized into modules with high level clustering. Global efficiency measures how efficient the network is in exchanging information at the global level.

Secondary Outcome Measures

Disability Rating Scale

Full Information

First Posted
March 14, 2013
Last Updated
March 24, 2015
Sponsor
IRCCS San Camillo, Venezia, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01820923
Brief Title
Transcranial Brain Stimulation in Vegetative State Patients
Official Title
Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain stimulation
Arm Type
Experimental
Arm Description
Brain stimulation will consist of 4 types of intervention: real transcranial direct current stimulation (two weeks, five days a week) a week of wash-out Sham transcranial direct current stimulation (two weeks, five days a week) two weeks of wash-out real repetitive transcranial magnetic stimulation (two weeks, four days a week) a week of wash-out Sham repetitive transcranial magnetic stimulation (two weeks, three days a week) Stimulations will be counterbalanced between patients.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Frequency of stimulation: 10Hz. Interstimulus interval: 1 min. Number of stimuli per session: 300. Number of sessions per week: 4 Total number of stimuli: 1.200
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (SHAM)
Intervention Description
The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (SHAM)
Intervention Description
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
Primary Outcome Measure Information:
Title
EEG coherence analysis
Description
EEG will be filtered between 0.5 and 30Hz by elliptic filters. Fast Fourier Transformation will be performed on 2 sec-epochs. For each stimulation site, coherence values will be estimated within four frequency bands: Delta (0.5-3.5 Hz), Theta (4-7.5 Hz), Alpha (8-12.5 Hz), and Beta (13-30 Hz). Each coherence map will be proportionally thresholded, preserving 50% of the strongest coherence values, to produce a weighted adjacency matrix. The estimated functional connectivity patterns will be characterized by means of two global network metrics derived from graph theory: modularity and global efficiency. Modularity measures how the network is organized into modules with high level clustering. Global efficiency measures how efficient the network is in exchanging information at the global level.
Time Frame
Change from baseline EEG coherence at the end of brain stimulation (two weeks)
Secondary Outcome Measure Information:
Title
Disability Rating Scale
Time Frame
Change from baseline DRS scale at the end of brain stimulation (two weeks)
Other Pre-specified Outcome Measures:
Title
Western Neuro Sensory Stimulation Profile (WNSSP)
Description
This scale is developed to assess cognitive function in severely impaired head-injured adults and to monitor and predict change in slow-to-recover patients.
Time Frame
Change from baseline WNSSP scale at the end of brain stimulation (two weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29. Age between 18 and 65 years. Time from the lesion: more than 4 months. Stable clinical condition. written consent fron the legal administrator of the patient. Exclusion Criteria: Presence of epileptiform activity on EEG. Previous history of epilepsy. Extensive hemorrhage or ischemia. Metallic clips or intracranial implants. Pacemaker e Baclofen infusion. Presence of drugs influencing arousal or awareness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Piccione, MD
Organizational Affiliation
San Camillo Foundation
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS San Camillo Foundation
City
Venice
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22624587
Citation
Giacino J, Fins JJ, Machado A, Schiff ND. Central thalamic deep brain stimulation to promote recovery from chronic posttraumatic minimally conscious state: challenges and opportunities. Neuromodulation. 2012 Jul;15(4):339-49. doi: 10.1111/j.1525-1403.2012.00458.x. Epub 2012 May 24.
Results Reference
background
PubMed Identifier
20647501
Citation
Piccione F, Cavinato M, Manganotti P, Formaggio E, Storti SF, Battistin L, Cagnin A, Tonin P, Dam M. Behavioral and neurophysiological effects of repetitive transcranial magnetic stimulation on the minimally conscious state: a case study. Neurorehabil Neural Repair. 2011 Jan;25(1):98-102. doi: 10.1177/1545968310369802. Epub 2010 Jul 20.
Results Reference
result

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Transcranial Brain Stimulation in Vegetative State Patients

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