NCT04614792: VEG-TDCS

Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients

Completed NA Last updated 28 February 2024

What this trial tests

NA trial testing Transcranial direct current stimulation in Disorder of Consciousness in 16 participants. Completed in 27 December 2023.

Timeline

30 April 2014

Primary endpoint
27 December 2023

27 December 2023

Quick facts

Lead sponsor	Oded Meiron
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	30 April 2014
Primary completion	27 December 2023
Estimated completion	27 December 2023
Sites	1 location across Israel

Drugs / interventions tested

• Transcranial direct current stimulation

Conditions studied

• Disorder of Consciousness — all drugs for Disorder of Consciousness →
• MMN — all drugs for MMN →
• Modification of Cognitive Status Indication — all drugs for Modification of Cognitive Status Indication →
• Anoxic Brain Damage — all drugs for Anoxic Brain Damage →

Sponsor

Oded Meiron

Who can join

Adults 18 to 90, any sex, with Disorder of Consciousness or MMN. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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" .

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.