Transcranial Brain Stimulation in Vegetative State Patients

N/ACompletedNCT01820923

IRCCS San Camillo, Venezia, Italy40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Vegetative State Minimally Conscious State

Interventions

Transcranial direct current stimulation (tDCS)DEVICE

2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.

Repetitive Transcranial Magnetic Stimulation (rTMS)DEVICE

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

Transcranial Direct Current Stimulation (SHAM)DEVICE

The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS San Camillo Foundation

Venice, Venice, Italy

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline EEG coherence at the end of brain stimulation (two weeks)

Secondary Outcomes

Disability Rating Scale

Time frame: Change from baseline DRS scale at the end of brain stimulation (two weeks)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.