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NCT05675956
Acute Nerve Stimulation For Enhancing Human and Cognitive Performance
Conditions: Concussion, Mild, Autonomic Nervous System, Cognitive
Sex: All
Ages: 18 Years – 35 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 35
Sponsor: University of South Carolina
Location: United States
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.
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.
Source: ClinicalTrials.gov (NCT05675956). StuddyBuddy aggregates publicly available trial information.