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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
neuroConn_CE_DC-STIMULATOR
neuroConn_CE_DC-STIMULATOR
SHAM
Sponsored by
Loewenstein Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Executive function difficulties, Transcranial direct current stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Loewenstein Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Right

left

sham

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).

Full Information

First Posted
December 17, 2014
Last Updated
August 7, 2018
Sponsor
Loewenstein Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02331615
Brief Title
Application of Trans Cranial Direct Current Stimulation for Executive Dysfunction After Traumatic Brain Injury
Official Title
Feasibility of the Use of Electrical Stimulation Using tDCS to Influence Executive Abilities After Traumatic Brain Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Executive function difficulties, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right
Arm Type
Experimental
Arm Description
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.
Arm Title
left
Arm Type
Experimental
Arm Description
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.
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
neuroConn_CE_DC-STIMULATOR
Intervention Description
right frontal anodal stimulation
Intervention Type
Device
Intervention Name(s)
neuroConn_CE_DC-STIMULATOR
Intervention Description
left frontal anodal stimulation
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
no meaningful stimulation will be given
Primary Outcome Measure Information:
Title
Change from baseline MindStreams-NeuroTrax MINDSTREAMS-NEUROTRAX
Description
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
Time Frame
day 1 (twice), day 15, day 21
Secondary Outcome Measure Information:
Title
Change from baseline Behavior Rating Inventory of Executive Function- (Adult Version) BRIEF-A
Description
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.
Time Frame
day 1, day 21
Title
Change from baseline Wechsler Adult Intelligence Scale (WAIS-III )
Description
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).
Time Frame
day 1 (twice), day 15, day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Loewenstein Rehabilitation Center
City
Ra'anana
Country
Israel

12. IPD Sharing Statement

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

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