Transcranial Brain Stimulation in Vegetative State Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vegetative State Minimally Conscious State

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Brain stimulation

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.

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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)

Intervention Type DEVICE

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

Repetitive Transcranial Magnetic Stimulation (SHAM)

Intervention Type DEVICE

The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.

Interventions

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Transcranial direct current stimulation (tDCS)

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

Intervention Type DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Intervention Type DEVICE

Transcranial Direct Current Stimulation (SHAM)

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

Intervention Type DEVICE

Repetitive Transcranial Magnetic Stimulation (SHAM)

The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No