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Completed

NCT Number: NCT04155333

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

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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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.S. Army Aeromedical Research Laboratory

Fort Rucker, Alabama, 36362, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 18 (if active duty), 19 (if non-active duty) up to 40 years old.
  • Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and screening by study physician
  • Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by actigraphy data and self-report.
  • 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

  • The following medically-related exclusionary criteria will be used, as assessed and verified by the study physician:
  • 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
  • No current medical conditions or medications affecting cognitive function or attention.
  • Any history of any attention deficit condition requiring medication.
  • Any history of psychological/psychiatric disorder.
  • Any history of seizures, migraines, or neurological disorders.
  • History of a head injury involving loss of consciousness.
  • Any metal implanted within the head (e.g., shrapnel, surgical clips) or any implanted devices (e.g., cardiac pacemaker, brain stimulator, hydrocephalic shunt).
  • Skin condition on the scalp, such as psoriasis or eczema, or wounds on the head.
  • Currently receiving hormonal therapy treatments, other than birth control or as determined by physicians.
  • Potential for caffeine withdrawal symptoms that will impede cognitive testing.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Military task performance

    Time frame: Folllowing stimulation; task lasts approximately 20 min

    Patrol exertion multitask

  2. Military task performance

    Time frame: Folllowing stimulation; task lasts approximately 40 min

    Target acquisition

  3. Cognitive function - Selective Attention

    Time frame: Approximately 3 minutes during stimulation

    Stroop test

  4. Cognitive function - Multitasking/Working Memory

    Time frame: Approximately 5 minutes during stimulation

    Dual n-back

  5. Cognitive function - Working Memory

    Time frame: Approximately 2 minutes during stimulation

    Digit span task

  6. Cognitive function - Sustained attention

    Time frame: Approximately 7 minutes during stimulation

    Rapid Visual Information Processing Task

  7. Cognitive function - Executive function

    Time frame: Approximately 2 minutes during stimulation

    Shifting Attention Task: Digit symbol substitution task

Secondary outcomes

  1. Cognitive function - Impulsivity/Motor Control

    Time frame: Approximately 3 minutes after stimulation

    Stop signal task - response inhibition

  2. Cognitive function - Risk Taking/ Decision Making

    Time frame: Approximately 1 minute after stimulation

    Delayed Discounting Task

  3. Cognitive function - Cognitive Flexibility

    Time frame: Approximately 5 minutes after stimulation

    Uses Task

Other outcomes

  1. Confounding factor - Sleepiness

    Time frame: Approximately 1 minute, before and after stimulation

    Karolinska Sleepiness Scale

  2. Confounding factor - Circadian typology

    Time frame: Approximately 15 minutes during intake

    Morningness-Eveningness Questionnaire

  3. Moderator variable - Intelligence

    Time frame: Approximately 15 minutes during intake

    Shipley's Institute of Living Scale

  4. Moderator variable - Trait motivation

    Time frame: Approximately 10 minutes during intake

    Behavioral Avoidance/ Inhibition Scales

  5. Side effects - mood symptoms

    Time frame: Approximately 3 minutes before and after stimulation

    Profile of Mood States - Short Form

  6. Side effects - Physical side effects

    Time frame: Approximately 2 minutes before and after stimulation

    Symptom Checklist

  7. Side effects - Physiology/health

    Time frame: Approximately 5 minutes before and after stimulation

    Welch Allyn Connex 6000

Sponsors and collaborators

Lead sponsor

United States Army Aeromedical Research Laboratory

Fed

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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