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Non-invasive brain stimulation has been shown to alter performance in both clinical and healthy populations on cognitive tasks. While the performance alterations have generally been shown to result in enhancement, mixed results remain in the literature. Much of the mixed results within the literature have been attributed to the use of different stimulation parameters, targeting of different brain areas, and using a variety of performance measures or assessing different constructs. However, non-invasive brain stimulation is a desirable method for enhancing Soldier performance given the ease of administration and minimal side effects as compared to other forms of performance enhancement (e.g., pharmaceuticals, caffeine). The objective of the current study is to evaluate the effects of non-invasive brain stimulation to the left dorsolateral prefrontal cortex in enhancing Soldier cognitive skills and performance on military tasks. A double blind within-subjects design will be used with healthy, rested Soldiers who will receive non-invasive brain stimulation and perform basic cognitive and operationally relevant tasks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active anodal stimulation | Experimental | active anodal stimulation at F3, cathode placed on contralateral bicep |
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| Active cathodal stimulation | Experimental | active cathodal stimulation at F3, anode placed on contralateral bicep |
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| Sham stimulation | Sham Comparator | sham stimulation that will be counterbalanced between subjects such that half will receive sham stimulation configured as condition 1 (anode F3, cathode bicep) and half will receive condition 2 (cathode F3, anode bicep) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that stimulates the brain through the application of a low-intensity electrical current, typically ranging from 1 to 2 milliamps (mA), via electrodes placed on an individual's scalp. During the active stimulation sessions, 2 mA of stimulation will be applied for 30 minutes. During the sham stimulation session, 2 mA of stimulation will be applied over the course of 90 sec, the electrodes will remain in place for the 30 minute duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Military task performance | Patrol exertion multitask | Folllowing stimulation; task lasts approximately 20 min |
| Military task performance | Target acquisition | Folllowing stimulation; task lasts approximately 40 min |
| Cognitive function - Selective Attention | Stroop test | Approximately 3 minutes during stimulation |
| Cognitive function - Multitasking/Working Memory | Dual n-back | Approximately 5 minutes during stimulation |
| Cognitive function - Working Memory | Digit span task | Approximately 2 minutes during stimulation |
| Cognitive function - Sustained attention | Rapid Visual Information Processing Task | Approximately 7 minutes during stimulation |
| Cognitive function - Executive function | Shifting Attention Task: Digit symbol substitution task | Approximately 2 minutes during stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function - Impulsivity/Motor Control | Stop signal task - response inhibition | Approximately 3 minutes after stimulation |
| Cognitive function - Risk Taking/ Decision Making | Delayed Discounting Task |
| Measure | Description | Time Frame |
|---|---|---|
| Confounding factor - Sleepiness | Karolinska Sleepiness Scale | Approximately 1 minute, before and after stimulation |
| Confounding factor - Circadian typology | Morningness-Eveningness Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
The following medically-related exclusionary criteria will be used, as assessed and verified by the study physician:
Females with a known pregnancy, who test positively for pregnancy, or refuse the test will be excluded, given the lack of available research regarding the effects of tDCS during pregnancy. Known pregnancy will be assessed during screening, females without a known pregnancy will be requested to provide a urine sample during the screening procedures to ensure the absence of pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Katie Feltman, PhD | US Army Aeromedical Research Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Army Aeromedical Research Laboratory | Fort Rucker | Alabama | 36362 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2020 | Jan 5, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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A double-blind, randomized, sham-controlled, within-subjects design
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Subjects and the research team will both be blind to the stimulation condition delivered at each test session. Access will be limited to the study physicians, investigators, and device programmers.
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| Approximately 1 minute after stimulation |
| Cognitive function - Cognitive Flexibility | Uses Task | Approximately 5 minutes after stimulation |
| Approximately 15 minutes during intake |
| Moderator variable - Intelligence | Shipley's Institute of Living Scale | Approximately 15 minutes during intake |
| Moderator variable - Trait motivation | Behavioral Avoidance/ Inhibition Scales | Approximately 10 minutes during intake |
| Side effects - mood symptoms | Profile of Mood States - Short Form | Approximately 3 minutes before and after stimulation |
| Side effects - Physical side effects | Symptom Checklist | Approximately 2 minutes before and after stimulation |
| Side effects - Physiology/health | Welch Allyn Connex 6000 | Approximately 5 minutes before and after stimulation |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |