Skip to content

Effects of Non-Invasive Brain Stimulation on Soldiers' Cognitive and Functional Performance

Effects of Non-Invasive Brain Stimulation on Soldiers' Cognitive and Functional Performance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04155333
Enrollment
28
Registered
2019-11-07
Start date
2019-12-12
Completion date
2021-09-30
Last updated
2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Performance Enhancement

Brief summary

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.

Interventions

DEVICETranscranial direct current stimulation

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.

Sponsors

United States Army Aeromedical Research Laboratory
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Masking description

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.

Intervention model description

A double-blind, randomized, sham-controlled, within-subjects design

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Must be 18 (if active duty), 19 (if non-active duty) up to 40 years old. 2. Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and screening by study physician 3. Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by actigraphy data and self-report. 4. Must have refrained from consumption of caffeine, 16 hours, nicotine, 2 hours, and alcohol, 24 hours, prior to the study, assessed by self-report.

Exclusion criteria

1. The following medically-related exclusionary criteria will be used, as assessed and verified by the study physician: 1. Haven taken any medications which induce drowsiness, such as over-the-counter antihistamines within 24 hours of participation in the study. Any self-medication will be assessed through self-report 2. No current medical conditions or medications affecting cognitive function or attention. 3. Any history of any attention deficit condition requiring medication. 4. Any history of psychological/psychiatric disorder. 5. Any history of seizures, migraines, or neurological disorders. 6. History of a head injury involving loss of consciousness. 7. Any metal implanted within the head (e.g., shrapnel, surgical clips) or any implanted devices (e.g., cardiac pacemaker, brain stimulator, hydrocephalic shunt). 8. Skin condition on the scalp, such as psoriasis or eczema, or wounds on the head. 9. Currently receiving hormonal therapy treatments, other than birth control or as determined by physicians. 10. Potential for caffeine withdrawal symptoms that will impede cognitive testing. 2. 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.

Design outcomes

Primary

MeasureTime frameDescription
Military task performanceFolllowing stimulation; task lasts approximately 20 minPatrol exertion multitask
Cognitive function - Executive functionApproximately 2 minutes during stimulationShifting Attention Task: Digit symbol substitution task
Cognitive function - Sustained attentionApproximately 7 minutes during stimulationRapid Visual Information Processing Task
Cognitive function - Working MemoryApproximately 2 minutes during stimulationDigit span task
Cognitive function - Multitasking/Working MemoryApproximately 5 minutes during stimulationDual n-back
Cognitive function - Selective AttentionApproximately 3 minutes during stimulationStroop test

Secondary

MeasureTime frameDescription
Cognitive function - Risk Taking/ Decision MakingApproximately 1 minute after stimulationDelayed Discounting Task
Cognitive function - Impulsivity/Motor ControlApproximately 3 minutes after stimulationStop signal task - response inhibition
Cognitive function - Cognitive FlexibilityApproximately 5 minutes after stimulationUses Task

Other

MeasureTime frameDescription
Confounding factor - Circadian typologyApproximately 15 minutes during intakeMorningness-Eveningness Questionnaire
Side effects - Physiology/healthApproximately 5 minutes before and after stimulationWelch Allyn Connex 6000
Side effects - Physical side effectsApproximately 2 minutes before and after stimulationSymptom Checklist
Side effects - mood symptomsApproximately 3 minutes before and after stimulationProfile of Mood States - Short Form
Moderator variable - Trait motivationApproximately 10 minutes during intakeBehavioral Avoidance/ Inhibition Scales
Moderator variable - IntelligenceApproximately 15 minutes during intakeShipley's Institute of Living Scale
Confounding factor - SleepinessApproximately 1 minute, before and after stimulationKarolinska Sleepiness Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026