NCT05675956

Acute Nerve Stimulation For Enhancing Human and Cognitive Performance

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Concussion, Mild
• Autonomic Nervous System
• Cognitive

Interventions

Type	Name	Description
DEVICE	Experimental group with 100% intensity setting on Apollo Neuro device	The group will have the device set to 100% intensity at one of their two experimental visits.
DEVICE	Active Comparator group with 10% intensity setting on the Apollo Neuro device	The group will have the device set to 10% intensity at one of their two experimental visits.

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-03-27
• Completion: 2024-03-27
• First posted: 2023-01-09
• Last updated: 2024-03-28

Locations

1 site across 1 country: United States