NCT01820923

Transcranial Brain Stimulation in Vegetative State Patients

Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IRCCS San Camillo, Venezia, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-03-29
• Last updated: 2015-03-25

Locations

1 site across 1 country: Italy