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Nerve Stimulator

Nerve Stimulation Wearable for Post-Concussion Syndrome

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention and after three and six weeks of device use

Awards & highlights

Study Summary

This trial tests the effect of a wearable nerve stimulator on teens with post-concussion symptoms. It'll measure symptom relief, cognitive improvement and recovery. Participants will wear it daily for 6 weeks.

Who is the study for?

This trial is for adolescents who have been diagnosed with a concussion and are experiencing ongoing symptoms. They should be able to follow simple instructions and sit upright for at least 30 minutes. Those with severe brain injuries, schizophrenia, bipolar disorder, epilepsy, cerebral palsy, or severe sensory disorders cannot participate.Check my eligibility

What is being tested?

The study is testing the Apollo Neuro device—a wearable nerve stimulator—on its ability to lessen symptoms and cognitive issues caused by concussions in adolescents. Participants will use the device daily over six weeks while their recovery progress is monitored through assessments.See study design

What are the potential side effects?

Potential side effects of using the Apollo Neuro device may include discomfort at the site of wear or skin irritation due to prolonged contact with the device material. However, specific side effects related to this nerve stimulation technology will be closely observed during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention and after three and six weeks of device use

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention and after three and six weeks of device use

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention and after three and six weeks of device use for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in concussion symptoms from pre-injury levels

Changes in anxiety symptoms

Changes in balance

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Apollo Neuro GroupExperimental Treatment1 Intervention

The group will use the Apollo Neuro device daily for six weeks as an adjunct to their standard treatment plan.

Group II: Standard Treatment GroupActive Control1 Intervention

The group will follow their standard treatment plan.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Prisma Health-MidlandsOTHER

23 Previous Clinical Trials

2,726 Total Patients Enrolled

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,359 Total Patients Enrolled

Media Library

Apollo Neuro (Nerve Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05685121 — N/A

Concussion Research Study Groups: Standard Treatment Group, Apollo Neuro Group

Concussion Clinical Trial 2023: Apollo Neuro Highlights & Side Effects. Trial Name: NCT05685121 — N/A

Apollo Neuro (Nerve Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05685121 — N/A

Frequently Asked Questions

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

Is it possible to join this trial at the present moment?

"According to the records stored on clinicaltrials.gov, this experiment is actively recruiting participants with its first post being made on October 22nd 2021 and lastly edited January 6th 2023."

Answered by AI

What is the aggregate figure of participants in this clinical experiment?

"Correct. Records published on clinicaltrials.gov reveal that this medical trial, first posted to the site in October of 2021, is actively searching for 100 participants at 1 research centre. The project was last updated on January 6th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents

Robert Davis Moore 2021. "A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05685121.