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Transcranial Brain Stimulation in Vegetative State Patients

NCT01820923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Vegetative State
  • Minimally Conscious State

Interventions

DEVICE

Transcranial direct current stimulation (tDCS)

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

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

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.

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.

Sponsors & Collaborators

  • IRCCS San Camillo, Venezia, Italy

    lead OTHER

Principal Investigators

  • Francesco Piccione, MD · San Camillo Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820923 on ClinicalTrials.gov