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

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ClinicalTrials.gov Identifier: NCT02331615
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):

December 17, 2014
January 6, 2015
September 27, 2016
March 2013
December 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02331615 on ClinicalTrials.gov Archive Site
  • 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.
  • 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).
  • 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.
  • 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).
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Not Provided
 
Application of Trans Cranial Direct Current Stimulation for Executive Dysfunction After Traumatic Brain Injury
Feasibility of the Use of Electrical Stimulation Using tDCS to Influence Executive Abilities After Traumatic Brain Injury Patients

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.

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Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Device: neuroConn_CE_DC-STIMULATOR
    right frontal anodal stimulation
  • Device: neuroConn_CE_DC-STIMULATOR
    left frontal anodal stimulation
  • Device: SHAM
    no meaningful stimulation will be given
  • 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.
    Intervention: Device: neuroConn_CE_DC-STIMULATOR
  • 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.
    Intervention: Device: neuroConn_CE_DC-STIMULATOR
  • 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.
    Intervention: Device: SHAM

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2017
December 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact: Sara Lipkin +972-9-7709639 Mirp3@clalit.org.il
Israel
 
 
NCT02331615
18-11-LOE
Yes
Not Provided
Not Provided
yaron sacher, Loewenstein Hospital
Loewenstein Hospital
Not Provided
Not Provided
Loewenstein Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP