Transcranial Brain Stimulation in Vegetative State Patients

Minimally Conscious State Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820923
• Other study ID #: 2011.04
• Secondary ID: 288/08
• Status: Completed
• Phase: N/A
• First received: March 14, 2013
• Last updated: March 24, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

Device:
• Transcranial direct current stimulation (tDCS)
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
• 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
• 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.
• Repetitive Transcranial Magnetic Stimulation (SHAM)
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.

Locations

Country	Name	City	State
Italy	IRCCS San Camillo Foundation	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Piccione F, Cavinato M, Manganotti P, Formaggio E, Storti SF, Battistin L, Cagnin A, Tonin P, Dam M. Behavioral and neurophysiological effects of repetitive transcranial magnetic stimulation on the minimally conscious state: a case study. Neurorehabil Neu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Western Neuro Sensory Stimulation Profile (WNSSP)	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.	Change from baseline WNSSP scale at the end of brain stimulation (two weeks)	No
Primary	EEG coherence analysis	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.	Change from baseline EEG coherence at the end of brain stimulation (two weeks)	No
Secondary	Disability Rating Scale		Change from baseline DRS scale at the end of brain stimulation (two weeks)	No