Trial record 3 of 7 for:    Open Studies | "Persistent Vegetative State"

Transcranial Brain Stimulation in Vegetative State Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by IRCCS San Camillo, Venezia, Italy
Sponsor:
Information provided by (Responsible Party):
Marianna Cavinato, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier:
NCT01820923
First received: March 14, 2013
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Vegetative State
Minimally Conscious State
Device: Transcranial direct current stimulation (tDCS)
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Transcranial Direct Current Stimulation (SHAM)
Device: Repetitive Transcranial Magnetic Stimulation (SHAM)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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.

Further study details as provided by IRCCS San Camillo, Venezia, Italy:

Primary Outcome Measures:
  • EEG coherence analysis [ Time Frame: Change from baseline EEG coherence at the end of brain stimulation (two weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline DRS scale at the end of brain stimulation (two weeks) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Western Neuro Sensory Stimulation Profile (WNSSP) [ Time Frame: Change from baseline WNSSP scale at the end of brain stimulation (two weeks) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820923

Contacts
Contact: Marianna Cavinato, PhD 0039 041 2207 ext 207 marianna.cavinato@ospedalesancamillo.net
Contact: Francesco Piccione, MD 0039 041 2207 ext 208 francesco.piccione@ospedalesancamillo.net

Locations
Italy
IRCCS San Camillo Foundation Recruiting
Venice, Italy, 30126
Contact: Marianna Cavinato, PhD    0039 0412207 ext 207    marianna.cavinato@ospedalesancamillo.net   
Contact: Francesco Piccione, MD    0039 0412207 ext 208    francesco.piccione@ospedalesancamillo.net   
Sponsors and Collaborators
IRCCS San Camillo, Venezia, Italy
Investigators
Study Director: Francesco Piccione, MD San Camillo Foundation
  More Information

Publications:
Responsible Party: Marianna Cavinato, PhD, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier: NCT01820923     History of Changes
Other Study ID Numbers: 2011.04, 288/08
Study First Received: March 14, 2013
Last Updated: March 26, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014