What side effects are associated with this type of intervention?

Common treatments for concussion, particularly those involving nerve stimulation to modulate neural activity, such as transcutaneous electrical nerve stimulation (TENS) and other neuromodulation therapies, generally have mild side effects. These can include skin irritation at the site of electrode placement, mild discomfort or tingling sensations during use, and, in rare cases, headaches or dizziness. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh any risks.

What prior FDA approvals exist?

There are currently no FDA-approved drugs specifically for the treatment of concussion. However, neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have been explored for related conditions like depression and cognitive deficits, which can also be symptoms of concussion. These techniques aim to modulate neural activity and have shown promise in various clinical trials, suggesting potential applicability in concussion treatment.

What other types of research exist?

Promising alternatives to wearable nerve stimulators for concussion patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown potential in treating neurological conditions. 2) Hyperbaric Oxygen Therapy (HBOT), which involves breathing pure oxygen in a pressurized environment to promote healing and reduce inflammation. 3) Neurofeedback Therapy, a type of biofeedback that uses real-time monitoring of brain activity to teach self-regulation of brain function. These therapies are being explored for their potential benefits in reducing post-concussive symptoms and aiding recovery.

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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

Summary

This trial tests a wearable device called the Apollo Neuro Device in adolescents with long-lasting concussion symptoms. The device sends gentle vibrations to help balance the nervous system, aiming to reduce symptoms and improve recovery. Participants will use the device daily for several weeks and complete periodic assessments.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nerve stimulation treatments, such as the wearable nerve stimulator being studied, work by modulating neural activity to alleviate symptoms associated with concussions. These devices typically deliver electrical impulses to specific nerves, which can help reduce clinical symptom burden, improve cognitive function, and accelerate recovery. This is particularly important for concussion patients as it offers a non-invasive method to manage persistent symptoms, potentially improving their quality of life and aiding in faster rehabilitation.

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society.

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Who is running the clinical trial?

Prisma Health-MidlandsOTHER

23 Previous Clinical Trials

2,695 Total Patients Enrolled

University of South CarolinaLead Sponsor

217 Previous Clinical Trials

121,265 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

~26 spots leftby Sep 2025

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