Transcranial Brain Stimulation in Vegetative State Patients

Not Applicable

Completed

• Conditions: Minimally Conscious State; Vegetative State
• Interventions: Device: Transcranial direct current stimulation (tDCS); Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (SHAM); Device: Repetitive Transcranial Magnetic Stimulation (SHAM)

• Registration Number: NCT01820923
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain stimulation	Transcranial direct current stimulation (tDCS)	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.
Brain stimulation	Transcranial Direct Current Stimulation (SHAM)	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.
Brain stimulation	Repetitive Transcranial Magnetic Stimulation (rTMS)	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.
Brain stimulation	Repetitive Transcranial Magnetic Stimulation (SHAM)	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.

Primary Outcome Measures

Name	Time	Method
EEG coherence analysis	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 Outcome Measures

Name	Time	Method
Disability Rating Scale	Change from baseline DRS scale at the end of brain stimulation (two weeks)

Trial Locations

Locations (1)

IRCCS San Camillo Foundation; 🇮🇹 Venice, Italy