Back to resultsAcute Nerve Stimulation For Enhancing Human and Cognitive Performance
Primary Purpose
Concussion, Mild, Autonomic Nervous System, Cognitive
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental group with 100% intensity setting on Apollo Neuro device
Active Comparator group with 10% intensity setting on the Apollo Neuro device
Sponsored by
About this trial
This is an interventional other trial for Concussion, Mild
Eligibility Criteria
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.
Sites / Locations
- University of South Carolina Sport Science LabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Intensity
Low Intensity
Arm Description
The device will be set to 100% intensity for this group.
The device will be set to 10% intensity in this group
Outcomes
Primary Outcome Measures
Changes in dopamine
To determine if the device has an impact on dopamine levels
Changes in epinephrine
To determine if the device has an impact on epinephrine levels
Changes in norepinephrine
To determine if the device has an impact on norepinephrine levels
Changes in cortisol
To determine if the device has an impact on cortisol levels
Changes in arousal
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.
Sleep Quality
Index of sleep quality using the Neurology Quality of Life (Neuro-QOL) sleep subscale.
Changes in fatigue
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.
Changes in Marksmanship Accuracy
Simulated marksmanship using optical targetry
Changes in Marksmanship Reaction Time
Simulated marksmanship using optical targetry
Changes in cognitive flexibility by local switch cost RT (Switch Task)
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.
Changes in cognitive flexibility by local switch cost ACC (Switch Task)
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.
Changes in cognitive flexibility by local switch cost IES (Switch Task)
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).
Changes in global executive function by global cost RT (Switch Task)
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.
Changes in global executive function by global cost ACC (Switch Task)
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.
Changes in global executive function by global cost IES (Switch Task)
To determine if the device has an impact on global executive function by measuring global cost IES.
Changes in working memory by mixing cost RT (Switch Task)
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.
Changes in working memory by mixing cost ACC (Switch Task)
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.
Changes in working memory by mixing cost IES (Switch Task)
To determine if the device has an impact on working memory by measuring mixing cost IES.
Changes in attention (Switch Task)
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.
Changes in Inhibitory Control (Switch Task)
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.
Changes in attention and cognitive control by ACC (Switch Task)
To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition ACC.
Changes in attention and cognitive control by RT (Switch Task)
To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition RT.
Changes in attention and cognitive control by IES (Switch Task)
To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition IES.
Changes in Inhibitory Control (Go/No go)
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).
Changes in Attention (Go/No go)
To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).
Changes in Autonomic Nervous System Function (ANS) by linear metrics
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.
Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics
To determine if the device has an impact on ANS function by measuring heart rate variability represented by nonlinear (ApSaEn) time domain metric.
Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics
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.
Changes in Inhibitory Control by accuracy scores (Flanker Task)
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.
Changes in Inhibitory Control by average response time (Flanker Task)
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.
Changes in Inhibitory Control by commission errors (Flanker Task)
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.
Changes in Attention by accuracy (Flanker Task)
To determine if the device has an impact on attention measured by the accuracy scores for congruent-compatible Flanker task trials.
Changes in Attention by average response time (Flanker Task)
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.
Changes in Attention by omission errors (Flanker Task)
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.
Changes in Cognitive flexibility by accuracy (Flanker Task)
To determine if the device has an impact on cognitive flexibility by the accuracy scores for incongruent-incompatible Flanker task trials.
Changes in Cognitive flexibility by average response time (Flanker Task)
To determine if the device has an impact on cognitive flexibility measured by the average response time to incongruent-incompatible flanker task trials.
Changes in Cognitive control by post-error accuracy (Flanker Task)
To determine if the device has an impact on cognitive control measured by post-error accuracy on Flanker task trials following an error.
Changes in Cognitive control by sequential congruency effect (Flanker Task)
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.
Changes in Cognitive control by inverse efficiency (Flanker Task)
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.
Changes in Attentional Inhibition (Flanker Task)
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.
Changes in verbal learning (HVLT)
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.
Changes in memory recall (HVLT)
To determine if the device has an impact on memory by measuring delayed recall via the delayed recall score.
Changes in retention (HVLT)
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.
Changes in memory retention (HVLT)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05675956
First Posted
November 2, 2022
Last Updated
January 29, 2023
Sponsor
University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05675956
Brief Title
Acute Nerve Stimulation For Enhancing Human and Cognitive Performance
Official Title
Exploration of Acute Nerve Stimulation by Way of Novel ApolloNeuro™ Device and Its Influences on Physiological Function to Mediate Human Performance and Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Autonomic Nervous System, Cognitive
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will participate in both arms of the intervention.
Masking
Participant
Masking Description
This will be a single-blind study, the investigators will know which condition subjects are assigned at which visit.
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Intensity
Arm Type
Experimental
Arm Description
The device will be set to 100% intensity for this group.
Arm Title
Low Intensity
Arm Type
Active Comparator
Arm Description
The device will be set to 10% intensity in this group
Intervention Type
Device
Intervention Name(s)
Experimental group with 100% intensity setting on Apollo Neuro device
Intervention Description
The group will have the device set to 100% intensity at one of their two experimental visits.
Intervention Type
Device
Intervention Name(s)
Active Comparator group with 10% intensity setting on the Apollo Neuro device
Intervention Description
The group will have the device set to 10% intensity at one of their two experimental visits.
Primary Outcome Measure Information:
Title
Changes in dopamine
Description
To determine if the device has an impact on dopamine levels
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.
Title
Changes in epinephrine
Description
To determine if the device has an impact on epinephrine levels
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.
Title
Changes in norepinephrine
Description
To determine if the device has an impact on norepinephrine levels
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.
Title
Changes in cortisol
Description
To determine if the device has an impact on cortisol levels
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.
Title
Changes in arousal
Description
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.
Time Frame
Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.
Title
Sleep Quality
Description
Index of sleep quality using the Neurology Quality of Life (Neuro-QOL) sleep subscale.
Time Frame
Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.
Title
Changes in fatigue
Description
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.
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.
Title
Changes in Marksmanship Accuracy
Description
Simulated marksmanship using optical targetry
Time Frame
Will be assessed prior exercise (minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Marksmanship Reaction Time
Description
Simulated marksmanship using optical targetry
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in cognitive flexibility by local switch cost RT (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in cognitive flexibility by local switch cost ACC (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in cognitive flexibility by local switch cost IES (Switch Task)
Description
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).
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in global executive function by global cost RT (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in global executive function by global cost ACC (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in global executive function by global cost IES (Switch Task)
Description
To determine if the device has an impact on global executive function by measuring global cost IES.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in working memory by mixing cost RT (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in working memory by mixing cost ACC (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in working memory by mixing cost IES (Switch Task)
Description
To determine if the device has an impact on working memory by measuring mixing cost IES.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in attention (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Inhibitory Control (Switch Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in attention and cognitive control by ACC (Switch Task)
Description
To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition ACC.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in attention and cognitive control by RT (Switch Task)
Description
To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition RT.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in attention and cognitive control by IES (Switch Task)
Description
To determine if the device has an impact on attention and cognitive control by measuring heterogeneous condition IES.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Inhibitory Control (Go/No go)
Description
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).
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Attention (Go/No go)
Description
To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Autonomic Nervous System Function (ANS) by linear metrics
Description
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.
Time Frame
This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
Title
Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics
Description
To determine if the device has an impact on ANS function by measuring heart rate variability represented by nonlinear (ApSaEn) time domain metric.
Time Frame
This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
Title
Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics
Description
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.
Time Frame
This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
Title
Changes in Inhibitory Control by accuracy scores (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Inhibitory Control by average response time (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Inhibitory Control by commission errors (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Attention by accuracy (Flanker Task)
Description
To determine if the device has an impact on attention measured by the accuracy scores for congruent-compatible Flanker task trials.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Attention by average response time (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Attention by omission errors (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Cognitive flexibility by accuracy (Flanker Task)
Description
To determine if the device has an impact on cognitive flexibility by the accuracy scores for incongruent-incompatible Flanker task trials.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Cognitive flexibility by average response time (Flanker Task)
Description
To determine if the device has an impact on cognitive flexibility measured by the average response time to incongruent-incompatible flanker task trials.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Cognitive control by post-error accuracy (Flanker Task)
Description
To determine if the device has an impact on cognitive control measured by post-error accuracy on Flanker task trials following an error.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Cognitive control by sequential congruency effect (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Cognitive control by inverse efficiency (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in Attentional Inhibition (Flanker Task)
Description
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.
Time Frame
Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Title
Changes in verbal learning (HVLT)
Description
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.
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.
Title
Changes in memory recall (HVLT)
Description
To determine if the device has an impact on memory by measuring delayed recall via the delayed recall score.
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.
Title
Changes in retention (HVLT)
Description
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.
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.
Title
Changes in memory retention (HVLT)
Description
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.
Time Frame
Immediately post one hour recovery (hour 3) on experimental visits.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn M Arent, PhD
Phone
8035768394
Email
sarent@mailbox.sc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gianna F Mastrofini, MS
Phone
7034246509
Email
giannafm@email.sc.edu
Facility Information:
Facility Name
University of South Carolina Sport Science Lab
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn M. Arent, PhD
Phone
803-576-8394
Email
sarent@mailbox.sc.edu
First Name & Middle Initial & Last Name & Degree
Bridget A McFadden, PhD
Email
BM39@mailbox.sc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Acute Nerve Stimulation For Enhancing Human and Cognitive Performance
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