PENFS for Post-Concussion Syndrome

Overseen By Pari Mokhtari

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Orange County

Disqualifiers: Seizure disorders, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-10 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Percutaneous Electrical Nerve Field Stimulation (PENFS) can assist children with lingering pain and symptoms from a concussion or COVID-19. The study aims to determine if this device can reduce symptoms and improve daily functioning. Participants are divided into groups, with some receiving the active device immediately and others starting with a non-active version before trying the real device. Eligible children should have experienced post-concussion syndrome or post-COVID symptoms for over three months, without any other explanation for their symptoms, and should not have conditions like seizure disorders or implanted electrical devices. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research and potentially experience symptom relief.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Neurostim device is safe for children with post-concussion and post-Covid-19 symptoms?

Research shows that Percutaneous Electrical Nerve Field Stimulation (PENFS) is generally safe and well-tolerated in children. Studies have found that it can reduce symptoms like stomach pain and nausea, with benefits often lasting for months. No reports of serious side effects have emerged, indicating the treatment's safety. As more research is conducted, this method appears promising for helping children with post-concussion symptoms without causing major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Percutaneous Electrical Nerve Field Stimulation (PENFS) for post-concussion syndrome because it offers a non-invasive, drug-free alternative to current treatments like rest and medication. Unlike standard treatments that primarily focus on symptom management, PENFS uses electrical impulses to directly target the nerves, potentially speeding up recovery and reducing symptoms more effectively. This innovative approach could offer relief in a shorter time frame, with fewer side effects, making it an attractive option for those suffering from prolonged post-concussion symptoms.

What evidence suggests that this Neurostim device is effective for post-concussion syndrome?

Research has shown that Percutaneous Electrical Nerve Field Stimulation (PENFS) can alleviate pain and symptoms from post-concussion syndrome. This treatment uses a small device to send electrical signals through tiny needles placed on the outer ear. Early results suggest it can reduce symptoms and improve children's well-being and functioning after a concussion. Although more data is needed on its effectiveness for children with post-concussion syndrome, its mechanism—stimulating nerves to affect pain pathways—appears promising. In this trial, participants will be assigned to different groups, with some receiving active neurostim devices and others initially receiving sham devices. Studies are also exploring its potential benefits for improving symptoms after COVID-19. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Post-Concussion Syndrome.

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

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

Exclusion Criteria

Implanted electrical device

I have a seizure disorder.

I have a severe ear infection or skin condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Neurostim device, either active or sham, for 4 to 6 weeks depending on the group. The device is worn for 5 consecutive days each week.

6-10 weeks

Weekly device placements

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurological and cardiology testing.

4 weeks

Open-label extension (optional)

Participants in the sham group are offered active Neurostim devices after the initial study procedures.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous Electrical Nerve Field Stimulation (PENFS)

Trial Overview 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.

How Is the Trial Designed?

Group I: COVID Active Neurostim Device Experimental Treatment 1 Intervention

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

Group II: Active Neurostim Device Experimental Treatment 1 Intervention

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

Group III: Sham Neurostim Device Placebo Group 1 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.

Percutaneous Electrical Nerve Field Stimulation (PENFS) is already approved in United States, European Union for the following indications:

Approved in United States as PENFS for:

• Chronic pain
• Post-Concussion Syndrome (PCS)
• Post Covid-19 symptoms

Approved in European Union as PENFS for:

• Chronic pain
• Neuropathic pain
• Post-Concussion Syndrome (PCS)

Who Is Running the Clinical Trial?

Children's Hospital of Orange County

Lead Sponsor

Trials

38

Recruited

5,700+

Innovative Health Solutions

Collaborator

Trials

4

Recruited

210+

Innovative Health Solutions

Industry Sponsor

Trials

4

Recruited

210+

Published Research Related to This Trial

In a study of 22 patients with chronic neuropathic pain, peripheral nerve field stimulation (PNFS) led to an average pain reduction of 5.50 points on the visual analog scale, indicating significant efficacy in managing drug-resistant pain.

The procedure was found to be safe, with no early or long-term complications reported, suggesting that PNFS could be a viable option for patients who do not respond to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic neuropathic pain: a single institution experience. D'Ammando, A., Messina, G., Franzini, A., et al.[2018]

The Neuro-Stim System™ devices, used for pain relief through a minimally invasive procedure, have been deemed low-risk by various regulatory bodies, indicating a favorable safety profile.

In a study monitoring 1,207 devices and over 19,000 punctures, the incidence of adverse effects such as bleeding, dermatitis, and infections was quantified, providing valuable data on the safety of this neuromodulation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. Roberts, A., Sithole, A., Sedghi, M., et al.[2020]

Peripheral nerve field stimulation (PNFS) is a safe and effective therapy for treating neuropathic pain, as demonstrated in a case study of a 70-year-old woman who experienced significant pain relief after 25 sessions over five years.

The treatment provided sustained relief without the development of tolerance, making PNFS a viable option for patients who cannot or choose not to undergo permanent nerve implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigemino-Cervical Neuropathic Pain Relieved by Serially Repeated Peripheral Nerve Field Stimulation Without Tolerance: Case Report. Simpson, BA., Nannapaneni, R.[2022]

In a study of 41 patients with chronic low back pain, those who responded positively to Transcutaneous Electrical Nerve Stimulation (TENS) were highly likely (94%) to also benefit from subsequent Peripheral Nerve Field Stimulation (PNFS) treatment, indicating TENS can help predict PNFS success.

Patients who had a positive response to TENS not only showed significant improvement in pain reduction during the PNFS trial but also experienced better overall outcomes in quality of life measures (SF12v2) and disability (ODI) at three and six months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Predictive Value of Transcutaneous Electrical Nerve Stimulation for Patient Selection in Peripheral Nerve Field Stimulation for Chronic Low Back Pain: A Prospective Study. Schwarm, FP., Ott, M., Nagl, J., et al.[2022]

Percutaneous electrical neural field stimulation (PENFS) targeting the auricular branches of cranial nerves showed promising results in treating chronic pain in a female veteran with fibromyalgia and a male veteran with complex regional pain syndrome (CRPS), both of whom had not responded to conventional therapies.

PENFS is a minimally-invasive, non-pharmacologic treatment that may improve quality of life and reduce medication dependence, but more research is necessary to establish its effectiveness and application in complex pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Percutaneous electrical neural field stimulation in two cases of sympathetically-mediated pain. Fraser, L., Woodbury, A.[2019]

Peripheral nerve field stimulation (PNFS) was evaluated in a small cohort of 10 patients with intractable facial pain, showing significant reductions in pain intensity from an average of 9.3 preoperatively to 0.75 postoperatively after an average follow-up of 11.3 months.

The majority of patients (6 out of 8 who proceeded with implantation) reported complete absence of pain with stimulation, indicating that PNFS may be a highly effective treatment option for refractory facial pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for trigeminal neuralgia, trigeminal neuropathic pain, and persistent idiopathic facial pain. Klein, J., Sandi-Gahun, S., Schackert, G., et al.[2017]

Peripheral nerve field stimulation (PNFS) significantly improved pain intensity and disability scores in 39 patients with chronic low back pain over a follow-up period of six months, indicating its efficacy as a treatment option.

Despite high levels of anxiety and depression in the patients, these psychological factors did not negatively affect the outcomes of pain relief and quality of life measures after PNFS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Elevated Levels for Depression, Anxiety, and Subjective Mental Stress Have No Influence on Outcome Measures of Peripheral Nerve Field Stimulation for Chronic Low Back Pain-A Prospective Study. Schwarm, FP., Ott, M., Nagl, J., et al.[2022]

In a study of 83 patients with chronic headaches, peripheral nerve field stimulation (PNFS) led to an average pain reduction of 4.8 points on a scale of 0 to 10, with 41 out of 60 implanted patients experiencing over 50% pain relief after an average follow-up of 12.9 months.

PNFS also resulted in significant reductions in medication use (83% of patients decreased their analgesic intake), disability, and depression levels, indicating its potential as an effective and reversible treatment option for chronic headache conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic headache: 60 cases and long-term follow-up. Verrills, P., Rose, R., Mitchell, B., et al.[2022]

A minimally invasive wireless peripheral nerve stimulation (PNS) device significantly reduced pain in a patient with post-traumatic supraorbital neuralgia, lowering their pain score from 8 to 2 out of 10 over 12 to 24 months.

The procedure was safe, with no adverse events reported, and the stimulation was effective without causing any unpleasant sensations, demonstrating a promising treatment option for neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency Supraorbital Nerve Stimulation With a Novel Wireless Minimally Invasive Device for Post-Traumatic Neuralgia: A Case Report. Van Buyten, JP., Smet, I., Devos, M., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04978571?term=AREA%5BConditionSearch%5D(a%20field%20syndrome%20OR%20%22Armfield%20X-linked%20intellectual%20disability%20syndrome%22%20OR%20%22%20intellectual%20developmental%20disorder,%20X-linked,%20syndromic,%20Armfield%20type,%20X-linked%20recessive%22%20OR%20%22%20intellectual%20disability%20syndrome,%20X-linked,%20Armfield%20type%22%20OR%20%22%20mental%20retardation%20syndrome,%20X-linked,%20armfield%20type,%20X-linked%20recessive%22%20OR%20%22%20MRXSA%22%20OR%20%22%20syndromic%20X-linked%20intellectual%20disability%20Armfield%20type%22%20OR%20%22%20X-linked%20intellectual%20disability,%20Armfield%20type%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=4

Percutaneous Electrical Nerve Field Stimulation (PENFS) in ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04978571/percutaneous-electrical-nerve-field-stimulation-penfs-in-patients-with-post-concussion-syndrome-pcs

Percutaneous Electrical Nerve Field Stimulation (PENFS) ... The purpose of this study is to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on ...

3. withpower.com withpower.com/trial/phase-syndrome-1-2021-93ce9

PENFS for Post-Concussion Syndrome 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, ...

4. clinicaltrial.be clinicaltrial.be/en/details/41295?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Percutaneous Electrical Nerve Field Stimulation (PENFS) i... The purpose of this study is to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on ...

5. ir.neuraxis.com ir.neuraxis.com/news-releases/news-release-details/neuraxis-highlights-pediatric-post-concussion-clinical-study

NeurAxis Highlights Pediatric Post-Concussion Clinical Study This page discusses ongoing research activities with percutaneous electrical nerve field stimulator (PENFS) technology. Please note, the research being ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869640/

Percutaneous Electrical Nerve Field Stimulation (PENFS) in ... Improvements in abdominal pain, nausea, and functional disability were sustained at 6-12 months and benefits in anxiety and catastrophizing ...