Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Study Overview
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Brief Summary
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Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, the study team will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, the study team will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.

Official Title
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Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury: A Study of the Effect of Transcranial Electrical Stimulation of the Ventrolateral Prefrontal Cortex on Response Inhibition

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: transcranial direct current stimulation
* Device: transcranial pulsed current stimulation
* Device: Sham-no stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects referred to the PI for management of TBI Subject is at least 3 months post-injury at the time of consent Ages 25-70 Exclusion Criteria: Subjects with the inability to consent for themselves Subjects with body habitus that does not allow the EEG cap to be properly placed Presence of scalp injury or disease Allergic reaction to topical lidocaine jelly Prior intracranial surgery or skull-fracture over VLPFC Presence of hemorrhage on intracranial imaging Prior brain radiotherapy Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation Subjects with the inability to see and read from a computer screen History of any form of seizures prior to TBI or within 6 months of study participation Pregnancy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Direct Current Stimulation (tDCS)<br> | Device: transcranial direct current stimulation<br>* Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.<br>|
| Experimental: Transcranial Pulsed Stimulation tPCS<br> | Device: transcranial pulsed current stimulation<br>* Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.<br>|
| Sham Comparator: No Stimulation<br> | Device: Sham-no stimulation<br>* Subjects in this arm will receive one session of sham for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Reaction Time During Stop Signal Task | The Stop Signal Task (SST) is an assessment which requires participants to respond to various stimuli with a specific action and to not respond when a stop stimulus is presented. | Throughout study (1 hour) | 
| EEG power in all frequency bands | They will be fitted with a standard EEG cap consisting of 32 EEG electrodes placed in the 10/20 international system format, a standardized system for EEG electrode placement. Frequency bands will be measured. | Baseline and immediately post Stimulation |