Acute Nerve Stimulation For Enhancing Human and Cognitive Performance

NCT ID: NCT05675956

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-03-27

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.

Conditions

Concussion, Mild; Autonomic Nervous System; Cognitive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

High Intensity

The device will be set to 100% intensity for this group.

Group Type: EXPERIMENTAL

Experimental group with 100% intensity setting on Apollo Neuro device

Intervention Type: DEVICE

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

Low Intensity

The device will be set to 10% intensity in this group

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Shawn M. Arent

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Carolina Sport Science Lab

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

Pro00122153

Identifier Type: -

Identifier Source: org_study_id