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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vegetative State
- Sponsor
- IRCCS San Camillo, Venezia, Italy
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- EEG coherence analysis
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Marianna Cavinato
PhD
IRCCS San Camillo, Venezia, Italy
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Disability Rating Scale(Change from baseline DRS scale at the end of brain stimulation (two weeks))