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Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients (VEG-TDCS)

Primary Purpose

Disorder of Consciousness, MMN, Modification of Cognitive Status Indication

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Herzog Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Herzog Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active treatment

Arm Description

open label experimental treatment

Outcomes

Primary Outcome Measures

JFK COMA RECOVERY SCALE - REVISED
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
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.

Full Information

First Posted
October 29, 2020
Last Updated
October 30, 2020
Sponsor
Herzog Hospital
Collaborators
Neurosteer Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04614792
Brief Title
Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients
Acronym
VEG-TDCS
Official Title
Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients:Potential to Induce Modulation in Neurocognitive Features of Awareness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2014 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herzog Hospital
Collaborators
Neurosteer Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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" .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness, MMN, Modification of Cognitive Status Indication, Anoxic Brain Damage, Trauma, Brain, Vegetative State, EEG; Paroxysms, Occipital, Epilepsy of Childhood, Cortical Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open lable treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active treatment
Arm Type
Experimental
Arm Description
open label experimental treatment
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Non-invasive brain stimulation or neuromodulation.
Primary Outcome Measure Information:
Title
JFK COMA RECOVERY SCALE - REVISED
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
MMN ERP amplitudes
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oded Meiron, PhD
Phone
9725316856
Email
neuron.o.d.m@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efraim Jaul, MD
Organizational Affiliation
Herzog Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzog Medical Center
City
Jerusalem
ZIP/Postal Code
91035
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yehezkel Caine, MD
Phone
9725316817
Email
caine@herzoghospiltal.org
First Name & Middle Initial & Last Name & Degree
Oded Meiron, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Treatment methods and diagnostic methods will be shared as well as change in clinical and neurological status via research publication.
Citations:
PubMed Identifier
24035769
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.
Results Reference
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Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients

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