Transcranial Brain Stimulation in Vegetative State Patients

• Sponsor: IRCCS San Camillo, Venezia, Italy (Other)
• Overall Status: Completed
• CT.gov ID: NCT01820923
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 41
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vegetative State; Minimally Conscious State	Device: Transcranial direct current stimulation (tDCS); Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (SHAM); Device: Repetitive Transcranial Magnetic Stimulation (SHAM)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Disability Rating Scale [Change from baseline DRS scale at the end of brain stimulation (two weeks)]

Other Outcome Measures

1. Western Neuro Sensory Stimulation Profile (WNSSP) [Change from baseline WNSSP scale at the end of brain stimulation (two weeks)]

   This scale is developed to assess cognitive function in severely impaired head-injured adults and to monitor and predict change in slow-to-recover patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS San Camillo Foundation	Venice		Italy	30126

Sponsors and Collaborators

• IRCCS San Camillo, Venezia, Italy

Investigators

• Study Director: Francesco Piccione, MD, San Camillo Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

• Giacino J, Fins JJ, Machado A, Schiff ND. Central thalamic deep brain stimulation to promote recovery from chronic posttraumatic minimally conscious state: challenges and opportunities. Neuromodulation. 2012 Jul;15(4):339-49. doi: 10.1111/j.1525-1403.2012.00458.x. Epub 2012 May 24. Review.

• Responsible Party: Marianna Cavinato, PhD, IRCCS San Camillo, Venezia, Italy
• ClinicalTrials.gov Identifier: NCT01820923
• Other Study ID Numbers: 2011.04; 288/08
• First Posted: Mar 29, 2013
• Last Update Posted: Mar 25, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Persistent Vegetative State

Study Results

No Results Posted as of Mar 25, 2015