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

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of the Use of Electrical Stimulation Using tDCS to Influence Executive Abilities After Traumatic Brain Injury Patients

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: neuroConn_CE_DC-STIMULATOR
* Device: neuroConn_CE_DC-STIMULATOR
* Device: SHAM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right<br>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<br>* right frontal anodal stimulation<br>|
| Experimental: left<br>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<br>* left frontal anodal stimulation<br>|
| Sham Comparator: sham<br>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<br>* no meaningful stimulation will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline MindStreams-NeuroTrax MINDSTREAMS-NEUROTRAX | 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 | day 1 (twice), day 15, day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Behavior Rating Inventory of Executive Function- (Adult Version) BRIEF-A | 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. | day 1, day 21 | 
| Change from baseline Wechsler Adult Intelligence Scale (WAIS-III ) | 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). | day 1 (twice), day 15, day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Executive function difficulties, Transcranial direct current stimulation