Clinical trial NCT04614792: Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients
Official title: Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients:Potential to Induce Modulation in Neurocognitive Features of Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Consciousness
MMN
Modification of Cognitive Status Indication
Anoxic Brain Damage
Trauma, Brain
Vegetative State
EEG; Paroxysms, Occipital, Epilepsy of Childhood
Cortical Atrophy
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
Collaborators: name: Neurosteer Ltd.
First posted: 2020-11-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open lable treatment
Primary purpose: TREATMENT

Brief 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" .


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Intracranial metal implants
* Implanted devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* Active medical condition that would preclude medical stability for the study, including significant ECG abnormalities, cardiac arrhythmia, uncontrolled high blood pressure
* Participation in other research studies

Primary outcomes:
measure: JFK COMA RECOVERY SCALE - REVISED
timeFrame: 24 months
Secondary outcomes:
measure: MMN ERP amplitudes
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Medical Center
Study officials:
affiliation: Herzog Medical Center
name: Efraim Jaul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angelakis E, Liouta E, Andreadis N, Korfias S, Ktonas P, Stranjalis G, Sakas DE. Transcranial direct current stimulation effects in disorders of consciousness. Arch Phys Med Rehabil. 2014 Feb;95(2):283-9. doi: 10.1016/j.apmr.2013.09.002. Epub 2013 Sep 11.