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NCT04614792Completed

Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients

Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients:Potential to Induce Modulation in Neurocognitive Features of Awareness

Source: ClinicalTrials.gov · Last updated 28 Feb 2024

Brief summary (registry, in English)

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" .

Status (registry)
Completed
Study type
Interventional
Enrollment
16 (actual)
First submitted
29 Oct 2020
Start date
30 Apr 2014
Primary completion date
27 Dec 2023
Lead sponsor
Oded Meiron
Diseases
Epilepsy
NCT number
NCT04614792

What you commit to

  • Study type: Interventional
  • Participants enrolled: 16
  • From 30 Apr 2014 to the primary completion date, 27 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intracranial metal implants
  • Implanted devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)

Other illness

  • Active medical condition that would preclude medical stability for the study, including significant ECG abnormalities, cardiac arrhythmia, uncontrolled high blood pressure

Other

  • Participation in other research studies

Who the study is looking for

  • Anoxic brain damage/TBI/CVA/progressive dementia/encephalopathy
  • Vegetative state patients or minimally conscious state according to CRS-R criteria
  • Ages 18 to 90
  • Consent for participation in clinical study (e.g., informed consent) by legal guardian of patients.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Herzog Medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.