What is the mechanism of action of this treatment?

Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) and similar treatments work by delivering electrical impulses to specific nerve fields in the auricular (ear) region. These impulses modulate pain and improve neurological function by stimulating the release of neurotransmitters and endorphins, which can reduce pain perception and enhance mood. Additionally, this stimulation can influence brain plasticity, potentially aiding in the recovery of cognitive and neurological functions impaired by concussion. For PCS patients, these mechanisms are crucial as they address both the pain and cognitive symptoms commonly associated with the syndrome, offering a non-invasive and potentially effective treatment option.

What side effects are associated with this type of intervention?

Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) and similar treatments involving electrical stimulation of nerve fields generally have mild side effects. These can include sensations such as warmth, numbness, itching, tingling, muscle spasms, and localized pain in the area of stimulation. Serious adverse events are rare. Patients should discuss these potential side effects with their healthcare provider to determine the best course of action for their specific condition.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Post-Concussion Syndrome (PCS) mentioned in the provided context. However, Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) is being studied for its potential to modulate pain and improve neurological function in patients with PCS. This type of electrical stimulation targets nerve fields in the auricular region and is being explored as a complementary therapy to improve outcomes in patients with post-concussion symptoms.

What other types of research exist?

Promising novel alternatives to Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) for Post-Concussion Syndrome (PCS) patients include: 1) External Trigeminal Neurostimulation (eTNS), which has shown efficacy in acute migraine therapy and may have potential for PCS. 2) Remote Electrical Neuromodulation (REN), which has been effective in alleviating episodic migraine pain and could be adapted for PCS. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which has demonstrated benefits in acute migraine treatment and may offer relief for PCS symptoms. 4) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown modest effectiveness in chronic tinnitus and other neurological conditions, and could be explored for PCS management.

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Neurostimulation

PENFS for Post-Concussion Syndrome

N/A

Recruiting

Research Sponsored by Children's Hospital of Orange County

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of Post-Concussion Syndrome

Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms

Must not have

Seizure disorders

Infection or severe dermatological condition of ear

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Summary

This trial tests a small device that sends electrical signals through tiny needles on the outer ear to help children with pain, post-concussion symptoms, and post-COVID-19 symptoms. The electrical signals aim to reduce pain and improve brain function by stimulating nerves in the ear. The use of electrical currents for the treatment of disease has been considered since antiquity but it has only been in recent years that suitable devices have been available to scientific investigators to provide stimulation currents for clinical use.

Who is the study for?

This trial is for children who have been diagnosed with Post-Concussion Syndrome and have had symptoms for at least three months without other explanations. It's open to families that speak English or Spanish.

What is being tested?

The study tests Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS), a neurostimulation device, on children with pain and post-concussion symptoms, as well as those with lingering post-COVID-19 issues.

What are the potential side effects?

While the document doesn't specify side effects, similar nerve stimulation treatments can sometimes cause discomfort at the site of application, headache, dizziness or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Post-Concussion Syndrome.

Select...

I have had concussion symptoms for over 3 months with no other cause.

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My child has had COVID-19 symptoms for over 3 months with no other explanation for their condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a seizure disorder.

Select...

I have a severe ear infection or skin condition.

Select...

I have a bleeding disorder.

Select...

My child does not have severe skin conditions, bleeding disorders, or any implanted electrical devices and is not significantly developmentally delayed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Balance Error Scoring Symptom

COGNIGRAM

Immediate Post-Concussion Assessment

+1 more

Secondary study objectives

Abdominal Pain Index

Baxter Animated Retching Faces Nausea Scale

Children's Somatization inventory

+5 more

Other study objectives

Electrocardiography

Orthostatic Vitals

Pupillometry

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: COVID Active Neurostim DeviceExperimental Treatment1 Intervention

Patients in this group will receive the active devices for the 6 study weeks.

Group II: Active Neurostim DeviceExperimental Treatment1 Intervention

Patients in this group will receive the active devices for the initial 4 study weeks.

Group III: Sham Neurostim DevicePlacebo Group1 Intervention

Patients in this group will receive the sham devices for the initial 4 study weeks. However, they will be offered the 4 active devices after.

0 / 7Eligibility criteria met

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

Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) and similar treatments work by delivering electrical impulses to specific nerve fields in the auricular (ear) region. These impulses modulate pain and improve neurological function by stimulating the release of neurotransmitters and endorphins, which can reduce pain perception and enhance mood. Additionally, this stimulation can influence brain plasticity, potentially aiding in the recovery of cognitive and neurological functions impaired by concussion. For PCS patients, these mechanisms are crucial as they address both the pain and cognitive symptoms commonly associated with the syndrome, offering a non-invasive and potentially effective treatment option.

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society.Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache.