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

Loewenstein Hospital

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Device: neuroConn_CE_DC-STIMULATOR; Device: SHAM

Study type: Interventional

Funder types: Other

Identifiers

NCT02331615

18-11-LOE

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 3 patient groups

Right

Experimental group

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.

Treatment:

Device: neuroConn_CE_DC-STIMULATOR

Device: neuroConn_CE_DC-STIMULATOR

left

Experimental group

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.

Treatment:

Device: neuroConn_CE_DC-STIMULATOR

Device: neuroConn_CE_DC-STIMULATOR

sham

Sham Comparator group

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.

Treatment:

Device: SHAM