Transcranial Brain Stimulation in Vegetative State Patients

March 24, 2015 updated by: Marianna Cavinato, IRCCS San Camillo, Venezia, Italy

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Venice, Italy, 30126
        • IRCCS San Camillo Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain stimulation

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.
Device: Transcranial direct current stimulation (tDCS)
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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
Device: Transcranial Direct Current Stimulation (SHAM)
The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
Device: Repetitive Transcranial Magnetic Stimulation (SHAM)
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG coherence analysis
Time Frame: Change from baseline EEG coherence at the end of brain stimulation (two weeks)
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.
Change from baseline EEG coherence at the end of brain stimulation (two weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Disability Rating Scale
Time Frame: Change from baseline DRS scale at the end of brain stimulation (two weeks)
Change from baseline DRS scale at the end of brain stimulation (two weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Neuro Sensory Stimulation Profile (WNSSP)
Time Frame: Change from baseline WNSSP scale at the end of brain stimulation (two weeks)
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.
Change from baseline WNSSP scale at the end of brain stimulation (two weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Camillo, Venezia, Italy

Investigators

  • Study Director: Francesco Piccione, MD, San Camillo Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.04
  • 288/08 (Other Grant/Funding Number: Regional research funding)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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