Clinical trial NCT05675956: 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
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Autonomic Nervous System
Cognitive
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will participate in both arms of the intervention.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in dopamine
timeFrame: 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.
measure: Changes in epinephrine
timeFrame: 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.
measure: Changes in norepinephrine
timeFrame: 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.
measure: Changes in cortisol
timeFrame: 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.
measure: Changes in arousal
timeFrame: Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.
measure: Sleep Quality
timeFrame: Will be assessed at visits 2 and 3 prior exercise (minute 0) on experimental visits.
measure: Changes in fatigue
timeFrame: 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.
measure: Changes in Marksmanship Accuracy
timeFrame: Will be assessed prior exercise (minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Marksmanship Reaction Time
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in cognitive flexibility by local switch cost RT (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in cognitive flexibility by local switch cost ACC (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in cognitive flexibility by local switch cost IES (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in global executive function by global cost RT (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in global executive function by global cost ACC (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in global executive function by global cost IES (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in working memory by mixing cost RT (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in working memory by mixing cost ACC (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in working memory by mixing cost IES (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in attention (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Inhibitory Control (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in attention and cognitive control by ACC (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in attention and cognitive control by RT (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in attention and cognitive control by IES (Switch Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Inhibitory Control (Go/No go)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Attention (Go/No go)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Autonomic Nervous System Function (ANS) by linear metrics
timeFrame: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
measure: Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics
timeFrame: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
measure: Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics
timeFrame: This will be continuously assessed throughout the entirety of experimental visits 2 and 3 (minute 0 to about 3 hours)..
measure: Changes in Inhibitory Control by accuracy scores (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Inhibitory Control by average response time (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Inhibitory Control by commission errors (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Attention by accuracy (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Attention by average response time (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Attention by omission errors (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Cognitive flexibility by accuracy (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Cognitive flexibility by average response time (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Cognitive control by post-error accuracy (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Cognitive control by sequential congruency effect (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Cognitive control by inverse efficiency (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in Attentional Inhibition (Flanker Task)
timeFrame: Will be assessed prior exercise (about minute 30) and immediately following the bout of exercise (about hour 1.5) on experimental visits.
measure: Changes in verbal learning (HVLT)
timeFrame: 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.
measure: Changes in memory recall (HVLT)
timeFrame: 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.
measure: Changes in retention (HVLT)
timeFrame: 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.
measure: Changes in memory retention (HVLT)
timeFrame: Immediately post one hour recovery (hour 3) on experimental visits.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: