Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients

Status Completed

Clinical Trial Summary

In response to "conscious" EEG findings related to detectable cognitive function that reliably denote awareness in vegetative state patients, in the current study, we will assess the covert conscious EEG activity (as well as standard clinical overt measures) and neuroplasctic propensity (i.e., changes in EEG spectral power synchronization values following tDCS intervention) in vegetative-state patients receiving repetitive transcranial direct current stimulation (tDCS) treatment over frontal motor areas for a period of two weeks. In support of this approach, a recent tDCS study with vegetative and minimally conscious patients implied that a twenty minutes anodal stimulation (i.e., excitatory stimulation) to the left dorsolateral prefrontal cortex (DLPFC) significantly increased CRS-R scores versus sham (placebo: non-active stimulation) stimulation condition. It was noted that this tDCS effect was more pronounced in minimally conscious state patients versus vegetative state patients excluding effects of chronicity or etiology. Thus, the investigators in this study suggested that tDCS could be effective in improving cognitive recovery in severely brain-injured patients. However, their findings would benefit neural activation correlates that could support their conclusion regarding the effectiveness of this type of non-invasive intervention in promoting neurocognitive recovery. Most importantly, tDCS is safe for use in humans, has no adverse effects, is considered the most non-invasive transcranial stimulation method because it uses extremely weak currents (0.5 to 2 mA), and, is known to only temporarily shift the neuron's membrane potential towards excitation/inhibition. In regard to the method's potential to induce functional recovery in vegetative state patients, recent clinical studies indicate that tDCS could counteract the negative effects of brain damage by influencing neurophysiological mechanisms, and is likely to contribute to the "formation of functionally meaningful connections and the maintenance of existing pathways" .

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Anoxic Brain Damage
Brain Injuries
Brain Injuries, Traumatic
Consciousness Disorders
Cortical Atrophy
Disorder of Consciousness
EEG; Paroxysms, Occipital, Epilepsy of Childhood
Hypoxia, Brain
MMN
Modification of Cognitive Status Indication
Persistent Vegetative State
Trauma, Brain
Vegetative State

Clinical Trial Details

NCT number	NCT04614792
Study type	Interventional
Source	Herzog Hospital
Contact
Status	Completed
Phase	N/A
Start date	April 30, 2014
Completion date	December 27, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients — VEG-TDCS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms