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Application of Trans Cranial Direct Current Stimulation for Executive Dysfunction After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02331615
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often suffer from executive dysfunction and behavioral disturbances. These types of injuries often involve axonal damage to pre frontal brain areas, which mediate various cognitive and behavioral functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction, orbitofrontal circuit lesions lead to personality changes characterized by disinhibition and anterior cingulate circuit lesions present with apathy. Patients who suffered traumatic frontal lobe damage often demonstrate a lasting, profound disturbance of emotional regulation and social cognition.

Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes in the human motor cortex. this effect depends on the stimulation polarity and is specific to the site of stimulation. Interacting with cortical activity, by means of cortical stimulation, can positively affect the short-term cognitive performance and improve the rehabilitation potential of neurologic patients. In this respect, preliminary evidence suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect, and other cognitive disorders.

Several possible mechanisms can account for the effects of tDCS and other methods on cognitive performance. They all reflect the potential of these methods to improve the subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks. It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk during ambiguous decision making.

In this tDCS study the investigator uses one anode and one cathode electrode placed over the scalp to modulate a particular area of the central nervous system (CNS). The stimulation is administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on people.Electrode positioning is determined according to the International EEG 10-20 System.

Condition or disease Intervention/treatment
Traumatic Brain Injury Device: neuroConn_CE_DC-STIMULATOR Device: SHAM

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility of the Use of Electrical Stimulation Using tDCS to Influence Executive Abilities After Traumatic Brain Injury Patients
Study Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Right
Electrode positioning will be determined according to the EEG 10-20 international system for EEG electrode placement: Right hemisphere anodal stimulation of the dorso lateral frontal area (F3), left hemisphere catodal stimulation of the dorso lateral frontal area (F4). Intensity of 1.5 mA (milliampere) for duration of 15 minutes. A total of 9 sessions: 4 sessions a week for 2 weeks.
Device: neuroConn_CE_DC-STIMULATOR
right frontal anodal stimulation
Experimental: left
Electrode positioning will be determined according to the EEG 10-20 international system for EEG electrode placement: left hemisphere anodal stimulation of the dorso lateral frontal area (F3), right hemisphere catodal stimulation of the dorso lateral frontal area (F4). Intensity of mA1.5 (milliampere) for duration of 15 minutes. A total of 9 sessions: 4 sessions a week for 2 weeks.
Device: neuroConn_CE_DC-STIMULATOR
left frontal anodal stimulation
Sham Comparator: sham
The stimulator will be turned on for only a very short duration of time (msec) no meaningful stimulation is believed to be administered in such a way.
Device: SHAM
no meaningful stimulation will be given

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline MindStreams-NeuroTrax MINDSTREAMS-NEUROTRAX [ Time Frame: day 1 (twice), day 15, day 21 ]
    Computerized tests assess brain wellness across an array of cognitive domains including: memory, executive function, visual spatial perception, verbal function, attention, information processing speed, and motor skills. The psychometric properties of the tests exploit the advantages of computerized testing, providing precise accuracy and reaction time measurements. NeuroTrax offers an unbiased, standardized, accurate and inexpensive tool with a wide range of applicability. The specific tests that will be administered are Go-No Go Response Inhibition and Visual Spatial Processing

Secondary Outcome Measures :
  1. Change from baseline Behavior Rating Inventory of Executive Function- (Adult Version) BRIEF-A [ Time Frame: day 1, day 21 ]
    Measures an adult's views of him- or herself and captures important observer information for a comprehensive picture of the rated individual's executive functioning.

  2. Change from baseline Wechsler Adult Intelligence Scale (WAIS-III ) [ Time Frame: day 1 (twice), day 15, day 21 ]
    1. The WAIS-III, a subsequent revision of the WAIS and the WAIS-R, was released in 1997. It provided scores for Verbal IQ (Intelligence quotient ), Performance IQ, and Full Scale IQ, along with four secondary indices (Verbal Comprehension, Working Memory, Perceptual Organization, and Processing Speed).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Ages 18-70 years.
  • Traumatic Brain injured patients who were diagnosed with executive function difficulties.
  • Patients who are able to cooperate and comprehend simple instructions.
  • Patients who can provide informed consent after both oral and written information was given and discussed.

Exclusion Criteria:

  • Pregnancy.
  • Patients who sufferred a penetrating head trauma.
  • Patients who underwent a frontal craniotomy
  • Patients with a history of Psychiatric problems
  • In cases of Severe Porencephaly at stimulation site
  • Active Epilepsy or a history of seizure.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331615

Contact: Sara Lipkin +972-9-7709639 Mirp3@clalit.org.il

Loewenstein Rehabilitation Center Recruiting
Ra'anana, Israel
Contact: Sara Lipkin    +972-9-7709639    Mirp3@clalit.org.il   
Sponsors and Collaborators
Loewenstein Hospital
More Information


Responsible Party: yaron sacher, Application of Trans Cranial Direct Current stimulation for executive dysfunction after traumatic brain injury, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT02331615     History of Changes
Other Study ID Numbers: 18-11-LOE
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by yaron sacher, Loewenstein Hospital:
Traumatic Brain Injury
Executive function difficulties
Transcranial direct current stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System