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Completed

NCT Number: NCT05675956

Acute Nerve Stimulation For Enhancing Human and Cognitive Performance

The goal of this clinical trial is to test a wearable device's effect on performance in tactical populations with a history of concussion. The main question it aims to answer is the effectiveness of the device on modulate physiological and cognitive function.

The physiological function will be derived from metrics of heart rate variability and blood-based biomarkers, whilst human performance will be evaluated using tasks that assess cognitive domains of executive function, reaction time, and memory.

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Key information

Conditions

Concussion, Mild Autonomic Nervous System Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognitive Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

About this study

This study will compare the effects of two different settings of the ApolloNeuro™ Device on physiological and cognitive function. This device is worn on the wrist and produces silent low-frequency waves that feel like slight vibrations. The purpose of the device is to modulate autonomic nervous system function. There will be a total of 3 laboratory visits, each lasting approximately 3.5 hours, separated by 3-5 days to allow for physiological recovery. The first visit will include an exercise test to determine participants maximum exercise capacity and to familiarize participants with a battery of psycho-motor cognitive tasks. The remaining two visits will be experimental days differentiated by a low or high-intensity setting of the ApolloNeuro™ Device. The experimental order will be randomized. This means that neither the participant nor the research team will know which condition has been assigned. On the experimental days, participants will have blood drawn from their arm and complete psycho-motor cognitive measures before and after a 20-minute interval running workout. This study will help to acquire knowledge of how wearable devices may improve physiological and cognitive function.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant is between 18-30 BMI.
  • Participant needs to be either an ROTC member, currently employed military or law enforcement officer or are a military veteran or retired law enforcement officer who has completed service in the past 18 months.
  • Participant has provided written and dated informed consent.
  • Participant is in good health and able to participate in high-intensity exercise.
  • Participant have been clinically diagnosed with a concussion at least 3 months prior to screening and is asymptomatic.
  • Participant is willing to maintain their current dietary supplement usage through the duration of the study. If the participant began taking another supplement within the past month, the participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.

Exclusion criteria

  • Participant with any musculoskeletal injuries that would prevent exercising.
  • Participant with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
  • Participant with a history of hepatorenal, musculoskeletal, or autoimmune disease.
  • Participant with a personal history of heart disease, cardiovascular conditions, high blood pressure (systolic >140 mm Hg & diastolic >90 mm Hg), psychiatric disorders, neurological disorders, developmental disorders, cancer, benign prostate hypertrophy, gastric ulcer, reflux disease, or any other medical condition (i.e. visual/auditory) deemed exclusionary by the medical staff.
  • Participant currently taking medication that affects the ANS such as thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, anticoagulant, or psychotropic medications, or antihistamines.
  • Participant who is pregnant or lactating.
  • Participant with any of the following concussion characteristics; history of >3 concussions, loss of consciousness (>5 minutes), cause of injury related to violence e.g. physical altercations.
  • Participants with a history of moderate to severe TBI.

Treatment and study plan

Experimental group with 100% intensity setting on Apollo Neuro device

Device

The group will have the device set to 100% intensity at one of their two experimental visits.

Active Comparator group with 10% intensity setting on the Apollo Neuro device

Device

The group will have the device set to 10% intensity at one of their two experimental visits.

Primary outcomes

  1. Changes in dopamine

    Time frame: Will be assessed at visits 2 and 3 prior exercise (minute 0) , immediately following exercise (about 1.5 hour), and immediately post one hour recovery (at about hour 3) on experimental visits.

    To determine if the device has an impact on dopamine levels

  2. Changes in epinephrine

    Time frame: Will be assessed at visits 2 and 3 prior exercise (minute 0) , immediately following exercise (about 1.5 hour), and immediately post one hour recovery (at about hour 3) on experimental visits.

    To determine if the device has an impact on epinephrine levels

  3. Changes in norepinephrine

    Time frame: Will be assessed at visits 2 and 3 prior exercise (minute 0) , immediately following exercise (about 1.5 hour), and immediately post one hour recovery (at about hour 3) on experimental visits.

    To determine if the device has an impact on norepinephrine levels

  4. Changes in cortisol

    Time frame: Will be assessed at visits 2 and 3 prior exercise (minute 0) , immediately following exercise (about 1.5 hour), and immediately post one hour recovery (at about hour 3) on experimental visits.

    To determine if the device has an impact on cortisol levels

  5. Changes in arousal

    Time frame: Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.

    To determine if the device has an impact on arousal levels measured by the "Felt Arousal Scale". The minimum score is 1 and maximum score is 6. These measures are not indicative of better or worse outcomes.

  6. Sleep Quality

    Time frame: Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.

    Index of sleep quality using the Neurology Quality of Life (Neuro-QOL) sleep subscale.

  7. Changes in fatigue

    Time frame: Will be assessed prior exercise (minute 0), immediately after the bout of exercise (about hour 1.5), post cognitive testing (about 2 hour), and immediately post one hour recovery (about hour 3) on experimental visits.

    To determine if the device has an impact on fatigue levels measured by the "Fatigue Scale". The minimum score is 1 and maximum score is 5. These measures are not indicative of better or worse outcomes.

  8. Changes in Marksmanship Accuracy

    Time frame: Will be assessed prior exercise (minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    Simulated marksmanship using optical targetry

  9. Changes in Marksmanship Reaction Time

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    Simulated marksmanship using optical targetry

  10. Changes in cognitive flexibility by local switch cost RT (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive flexibility by measuring local switch cost RT within the heterogenous condition when switching rule sets represented as the additional time to respond to switch relative to repeat trials.

  11. Changes in cognitive flexibility by local switch cost ACC (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive flexibility by measuring local switch cost ACC within the heterogenous condition when switching rule sets represented as the difference between error rates for switch relative to repeat trials.

  12. Changes in cognitive flexibility by local switch cost IES (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive flexibility by measuring local switch cost inverse efficiency scores (IES) represented as dividing RTs by 1 minus the percentage of errors (i.e., percentage of correct responses).

  13. Changes in global executive function by global cost RT (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on global executive function by measuring global cost RT represented as the difference between the time required to respond between the heterogeneous and homogeneous conditions.

  14. Changes in global executive function by global cost ACC (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on global executive function by measuring global cost ACC represented as the difference between error rates between homogeneous and heterogeneous conditions.

  15. Changes in global executive function by global cost IES (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on global executive function by measuring global cost IES.

  16. Changes in working memory by mixing cost RT (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on working memory by measuring mixing cost RT represented as the additional time required to respond between the repeat trials in the heterogenous condition relative to the trials in the homogeneous condition.

  17. Changes in working memory by mixing cost ACC (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on working memory by measuring mixing cost ACC represented as the difference in error rates on repeat trials in the heterogenous condition relative to the trials in the homogeneous condition.

  18. Changes in working memory by mixing cost IES (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on working memory by measuring mixing cost IES.

  19. Changes in attention (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention measured by the omission errors when an individual fails to respond to a color-switch task trial, and omission error runs when an individual fails to respond to multiple successive trials.

  20. Changes in Inhibitory Control (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on inhibitory control measured by the commission errors when an individual fails to respond correctly to a color-switch task trial, and commission error runs when an individual fails to respond correctly to multiple successive trials.

  21. Changes in attention and cognitive control by ACC (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition ACC.

  22. Changes in attention and cognitive control by RT (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition RT.

  23. Changes in attention and cognitive control by IES (Switch Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition IES.

  24. Changes in Inhibitory Control (Go/No go)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on inhibitory control by measuring reaction time to Go targets (hits).

    To determine if the device has an impact on inhibitory control by measuring errors of commission representing incorrect responses to the target NoGo (false alarm).

  25. Changes in Attention (Go/No go)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).

  26. Changes in Autonomic Nervous System Function (ANS) by linear metrics

    Time frame: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..

    To determine if the device has an impact on ANS function by measuring heart rate variability represented by linear (RMSSD, SDNN, CVNN) time domain metrics.

  27. Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics

    Time frame: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..

    To determine if the device has an impact on ANS function by measuring heart rate variability represented by nonlinear (ApSaEn) time domain metric.

  28. Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics

    Time frame: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..

    To determine if the device has an impact on ANS function by measuring heart rate variability represented by frequency domain (HF, LF, Coherence Ratio) metrics.

  29. Changes in Inhibitory Control by accuracy scores (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on inhibitory control measured by the accuracy scores (% of correct answers) for compatible-congruent, incompatible-congruent, compatible-incongruent, and incompatible-incongruent Flanker Task trials.

  30. Changes in Inhibitory Control by average response time (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on inhibitory control measured by the average response time to incongruent flanker task trials irrespective of compatible or incompatible rule sets.

  31. Changes in Inhibitory Control by commission errors (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on inhibitory control measured by the commission errors when an individual fails to respond correctly to a flanker task trial, and commission error runs when an individual fails to respond correctly to multiple successive trials.

  32. Changes in Attention by accuracy (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention measured by the accuracy scores for congruent-compatible Flanker task trials.

  33. Changes in Attention by average response time (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention measured by the overall average response time (milliseconds) to compatible and incompatible Flanker task trails irrespective of trial congruency.

  34. Changes in Attention by omission errors (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attention measured by the omission errors when an individual fails to respond to a flanker task trial, and omission error runs when an individual fails to respond to multiple successive trials.

  35. Changes in Cognitive flexibility by accuracy (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive flexibility by the accuracy scores for incongruent-incompatible Flanker task trials.

  36. Changes in Cognitive flexibility by average response time (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive flexibility measured by the average response time to incongruent-incompatible flanker task trials.

  37. Changes in Cognitive control by post-error accuracy (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive control measured by post-error accuracy on Flanker task trials following an error.

  38. Changes in Cognitive control by sequential congruency effect (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine changes in cognitive control measured by sequential congruency effect when lower interference occurs following an incongruent relative to a congruent flanker task trial reflecting a consciously controlled narrowing of attention to the central target.

  39. Changes in Cognitive control by inverse efficiency (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on cognitive control measured by inverse efficiency a metric of a speed-accuracy trade-off for Flanker task trials.

  40. Changes in Attentional Inhibition (Flanker Task)

    Time frame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.

    To determine if the device has an impact on attentional inhibition measured by congruency interference representing the costs associated with the interference demands associated with incongruent vs congruent flanker task trials.

  41. Changes in verbal learning (HVLT)

    Time frame: Will be assessed prior exercise (about minute 30), immediately following the bout of exercise (about 1.5 hours), and immediately post one hour recovery (about hour 3) on experimental visits.

    To determine if the device has an impact on verbal learning by measuring total recall score via combining the word recall score from the three trials.

  42. Changes in memory recall (HVLT)

    Time frame: Will be assessed prior exercise (about minute 30), immediately following the bout of exercise (about 1.5 hours), and immediately post one hour recovery (about hour 3) on experimental visits.

    To determine if the device has an impact on memory by measuring delayed recall via the delayed recall score.

  43. Changes in retention (HVLT)

    Time frame: Will be assessed prior exercise (about minute 30), immediately following the bout of exercise (about 1.5 hours), and immediately post one hour recovery (about hour 3) on experimental visits.

    To determine if the device has an impact on memory by measuring retention via dividing the delayed recall trial by the score obtained on the trial prior exercise.

  44. Changes in memory retention (HVLT)

    Time frame: Immediately post one hour recovery (hour 3) on experimental visits.

    To determine if the device has an impact on memory by measuring retention via calculating a retention discrimination index by subtracting the total number of false positives from the total number of true positives.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Exploration of Acute Nerve Stimulation by Way of Novel ApolloNeuro™ Device and Its Influences on Physiological Function to Mediate Human Performance and Cognition

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
Mar 28, 2024

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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