Concussion, MildNCT05675956
Acute Nerve Stimulation For Enhancing Human and Cognitive Performance
A study testing Experimental group with 100% intensity setting on Apollo Neuro device and Active Comparator group with 10% intensity setting on the Apollo Neuro device in people with Concussion, Mild and Autonomic Nervous System, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Autonomic Nervous System, Cognitive
- What is being tested?
- Experimental group with 100% intensity setting on Apollo Neuro device and Active Comparator group with 10% intensity setting on the Apollo Neuro device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
About this study
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
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.
Read the 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.
- Conditions
- Concussion, Mild, Autonomic Nervous System, Cognitive
- Being tested
- Experimental group with 100% intensity setting on Apollo Neuro device, Active Comparator group with 10% intensity setting on the Apollo Neuro device
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group with 100% intensity setting on Apollo Neuro deviceDevice
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 deviceDevice
The group will have the device set to 10% intensity at one of their two experimental visits.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity | Experimental | The device will be set to 100% intensity for this group. Receives: Device: Experimental group with 100% intensity setting on Apollo Neuro device |
| Low Intensity | Active comparator | The device will be set to 10% intensity in this group Receives: Device: Active Comparator group with 10% intensity setting on the Apollo Neuro device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dopamine
To determine if the device has an impact on dopamine levels
Measured: 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.
Changes in epinephrine
To determine if the device has an impact on epinephrine levels
Measured: 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.
Changes in norepinephrine
To determine if the device has an impact on norepinephrine levels
Measured: 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.
Changes in cortisol
To determine if the device has an impact on cortisol levels
Measured: 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.
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.
Measured: Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.
Sleep Quality
Index of sleep quality using the Neurology Quality of Life (Neuro-QOL) sleep subscale.
Measured: Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.
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.
Measured: 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.
Changes in Marksmanship Accuracy
Simulated marksmanship using optical targetry
Measured: Will be assessed prior exercise (minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
Changes in Marksmanship Reaction Time
Simulated marksmanship using optical targetry
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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).
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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).
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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).
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
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.
Measured: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
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.
Measured: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
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.
Measured: 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.
Changes in memory recall (HVLT)
To determine if the device has an impact on memory by measuring delayed recall via the delayed recall score.
Measured: 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.
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.
Measured: 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.
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.
Measured: Immediately post one hour recovery (hour 3) on experimental visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Jan 2023
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will participate in both arms of the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675956
- Sponsor's protocol ID
- Pro00122153
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05675956
- Acronym / sponsor ID
- Pro00122153
- Conditions
- Concussion, Mild, Autonomic Nervous System, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will participate in both arms of the intervention.
| Arm | Type | Receives |
|---|---|---|
| High Intensity | Experimental | Device: Experimental group with 100% intensity setting on Apollo Neuro deviceThe device will be set to 100% intensity for this group. |
| Low Intensity | Active comparator | Device: Active Comparator group with 10% intensity setting on the Apollo Neuro deviceThe device will be set to 10% intensity in this group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group with 100% intensity setting on Apollo Neuro deviceThe group will have the device set to 100% intensity at one of their two experimental visits. | Device | High Intensity |
| Active Comparator group with 10% intensity setting on the Apollo Neuro deviceThe group will have the device set to 10% intensity at one of their two experimental visits. | Device | Low Intensity |
Primary outcome
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
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
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
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
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.
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.
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.
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
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
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group with 100% intensity setting on Apollo Neuro device and Active Comparator group with 10% intensity setting on the Apollo Neuro device in people with Concussion, Mild and Autonomic Nervous System, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.