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Completed

NCT Number: NCT02331615

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

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loewenstein Rehabilitation Center

Raanana, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

neuroConn_CE_DC-STIMULATOR

Device

right frontal anodal stimulation

SHAM

Device

no meaningful stimulation will be given

Primary outcomes

  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 outcomes

  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

    • 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).

Sponsors and collaborators

Lead sponsor

Loewenstein Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2015
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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