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Completed

NCT Number: NCT01820923

Transcranial Brain Stimulation in Vegetative State Patients

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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Key information

Conditions

Vegetative State Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Minimally Conscious State Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Camillo Foundation

Venice, 30126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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

Repetitive transcranial magnetic stimulation (rTMS)

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)

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)

Device

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

Primary outcomes

  1. EEG coherence analysis

    Time frame: 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 outcomes

  1. Disability Rating Scale

    Time frame: Change from baseline DRS scale at the end of brain stimulation (two weeks)

Other outcomes

  1. Western Neuro Sensory Stimulation Profile (WNSSP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 29, 2013
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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