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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herzog Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.