Transcranial Brain Stimulation in Vegetative State Patients

IRCCS San Camillo, Venezia, Italy

Status: Completed

Conditions: Vegetative State; Minimally Conscious State

Treatments: Device: Transcranial Direct Current Stimulation (SHAM); Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Repetitive Transcranial Magnetic Stimulation (SHAM); Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01820923

2011.04

288/08 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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40 participants in 1 patient group

Brain stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation (SHAM)

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Device: Repetitive Transcranial Magnetic Stimulation (SHAM)

Device: Transcranial direct current stimulation (tDCS)