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Behavioural Intervention

Nerve Stimulation for Concussion

N/A

Waitlist Available

Research Sponsored by University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial tests a device to help people with concussion improve their performance. It measures heart rate, biomarkers, and how well they do on tasks.

Who is the study for?

This trial is for individuals aged 18-30 with a BMI in the normal range, who are ROTC members, active or retired military/law enforcement personnel. Participants must have had a concussion at least 3 months ago but currently show no symptoms. They should be able to do high-intensity exercise and agree to keep their supplement intake consistent throughout the study.Check my eligibility

What is being tested?

The trial tests how well a wearable device called Apollo Neuro can improve physiological and cognitive functions in people with past concussions. One group will use the device at full intensity, while another at minimal intensity, to compare effects on heart rate variability, blood markers, executive function, reaction time, and memory.See study design

What are the potential side effects?

Potential side effects of using the Apollo Neuro device may include discomfort where it's worn or skin irritation due to its materials. Since it involves nerve stimulation, some participants might experience tingling sensations or temporary changes in heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Attention (Go/No go)

Changes in Attention by accuracy (Flanker Task)

Changes in Attention by average response time (Flanker Task)

+41 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High IntensityExperimental Treatment1 Intervention

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

Group II: Low IntensityActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental group with 100% intensity setting on Apollo Neuro device

2023

N/A

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,424 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged twenty and older eligible to participate in the clinical trial?

"This research initiative is accepting participants aged eighteen and above, but below the age of thirty-five."

Answered by AI

Are there any open slots to participate in this trial?

"Affirmative. Clinicaltrials.gov confirms that this medical trial is actively recruiting as of now, with a first posting on January 15th 2023 and last update occurring on the 9th of the same month. 35 participants are needed to be recruited from one location only."

Answered by AI

How many individuals are participating in this clinical research?

"Correct. According to information on clinicaltrials.gov, this medical study is in its active recruitment phase, having been first posted on January 15th 2023 and updated most recently on the 9th of that same month. 35 patients are needed from one site specifically."

Answered by AI

Who is the ideal cohort for this experimental research?

"This trial is recruiting 35 persons aged 18 to 35 who have autonomic nervous systems. In addition, they must be ROTC members, currently employed military personnel or law enforcement officers, veterans of either the armed forces or police service who have completed their term within the past eighteen months and are willing to provide written consent for participation. Furthermore, these individuals need to maintain a healthy lifestyle with a body mass index between 18-30 and abstain from taking any dietary supplements two weeks before joining if they started using one during that month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acute Nerve Stimulation For Enhancing Human and Cognitive Performance

Shawn M. Arent 2023. "Acute Nerve Stimulation For Enhancing Human and Cognitive Performance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05675956.