Transcranial Brain Stimulation in Vegetative State Patients
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.
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
March 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 25, 2015
March 1, 2015
3.4 years
March 14, 2013
March 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline EEG coherence at the end of brain stimulation (two weeks)
Secondary Outcomes (1)
Disability Rating Scale
Change from baseline DRS scale at the end of brain stimulation (two weeks)
Other Outcomes (1)
Western Neuro Sensory Stimulation Profile (WNSSP)
Change from baseline WNSSP scale at the end of brain stimulation (two weeks)
Study Arms (1)
Brain stimulation
EXPERIMENTALBrain 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.
Interventions
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
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
The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Camillo Foundation
Venice, Venice, 30126, Italy
Related Publications (2)
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.
PMID: 22624587BACKGROUNDPiccione 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.
PMID: 20647501RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francesco Piccione, MD
San Camillo Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 14, 2013
First Posted
March 29, 2013
Study Start
July 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 25, 2015
Record last verified: 2015-03