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Clinical Trials/NCT04155333
NCT04155333
Completed
Not Applicable

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

United States Army Aeromedical Research Laboratory1 site in 1 country28 target enrollmentDecember 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Performance Enhancement
Sponsor
United States Army Aeromedical Research Laboratory
Enrollment
28
Locations
1
Primary Endpoint
Cognitive function - Working Memory
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2019
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
United States Army Aeromedical Research Laboratory
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Cognitive function - Working Memory

Time Frame: Approximately 2 minutes during stimulation

Digit span task

Cognitive function - Sustained attention

Time Frame: Approximately 7 minutes during stimulation

Rapid Visual Information Processing Task

Military task performance

Time Frame: Folllowing stimulation; task lasts approximately 40 min

Target acquisition

Cognitive function - Multitasking/Working Memory

Time Frame: Approximately 5 minutes during stimulation

Dual n-back

Cognitive function - Selective Attention

Time Frame: Approximately 3 minutes during stimulation

Stroop test

Cognitive function - Executive function

Time Frame: Approximately 2 minutes during stimulation

Shifting Attention Task: Digit symbol substitution task

Secondary Outcomes

  • Cognitive function - Cognitive Flexibility(Approximately 5 minutes after stimulation)
  • Cognitive function - Risk Taking/ Decision Making(Approximately 1 minute after stimulation)
  • Cognitive function - Impulsivity/Motor Control(Approximately 3 minutes after stimulation)

Study Sites (1)

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