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

August 7, 2018 updated by: yaron sacher, Loewenstein Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ra'anana, Israel
        • Loewenstein Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
Device: neuroConn_CE_DC-STIMULATOR
left 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
right frontal anodal stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
day 1, day 21
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).
day 1 (twice), day 15, day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loewenstein Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 21, 2017

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

January 4, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-11-LOE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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