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

Sponsor

Herzog Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04614792

Collaborator

Neurosteer Ltd. (Industry)

Enrollment

Location

Arm

107

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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" .

Condition or Disease	Intervention/Treatment	Phase
Disorder of Consciousness MMN Modification of Cognitive Status Indication Anoxic Brain Damage Trauma, Brain Vegetative State EEG; Paroxysms, Occipital, Epilepsy of Childhood Cortical Atrophy	Device: Transcranial direct current stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

open lable treatmentopen lable treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 30, 2014

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: active treatment open label experimental treatment	Device: Transcranial direct current stimulation Non-invasive brain stimulation or neuromodulation.

Arm

Intervention/Treatment

Experimental: active treatment

open label experimental treatment

Device: Transcranial direct current stimulation

Non-invasive brain stimulation or neuromodulation.

Outcome Measures

Primary Outcome Measures

JFK COMA RECOVERY SCALE - REVISED [24 months]
JFK Coma recovery Scale - Revised scores for diagnosing disorders of consciousness. This cynical assessment scale examines reflexive behaviors such as response to pain and startle, and touch. The CRS consists of 25 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, oro- motor, communication, and arousal processes. Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors. sub scales represent motor function, auditory function, visual function sub scales and arousal sub scales. The low scores indicate low levels of functioning and the higher score indicate high levels of function an awareness. Maximum score is 23 and a minimal score is 0.

Secondary Outcome Measures

MMN ERP amplitudes [2 weeks]
Prefronal-Temopral cortex neuroplasticity and reactivity to sound : size of early auditory processing ERP amplitudes. If the negative change in ERP amplitudes is larger than in indicates better change-detection and neurplasticity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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