PENFS for Post-Concussion Syndrome

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital of Orange County

Disqualifiers: Seizure disorders, Developmental delay, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Percutaneous Electrical Nerve Field Stimulation (PENFS) for Post-Concussion Syndrome?

Research shows that similar treatments like Peripheral Nerve Field Stimulation (PNFS) have been effective for chronic pain conditions, including low back pain and headaches. Additionally, PENFS has shown promise in treating difficult pain syndromes like fibromyalgia and complex regional pain syndrome, suggesting it may help with other conditions involving nerve-related pain. ^{1 2 3 4 5}

Is PENFS generally safe for humans?

PENFS is considered a minimally invasive and generally safe procedure, with studies reporting minimal adverse effects such as localized bleeding, dermatitis (skin irritation), and infections at the implantation sites. ^{3 4 6 7 8}

How is the treatment PENFS unique for post-concussion syndrome?

PENFS is unique because it is a minimally-invasive, non-drug therapy that targets the ear's nerve branches to potentially improve symptoms without relying on medication, which is different from conventional treatments for post-concussion syndrome. ^{3 4 5 6 9}

Research Team

Eligibility Criteria

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

My child is between 11 and 18 years old.

My family speaks English or Spanish.

I have been diagnosed with Post-Concussion Syndrome.

Exclusion Criteria

Implanted electrical device

I have a seizure disorder.

I have a severe ear infection or skin condition.

Trial Timeline

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

Treatment Details

Interventions

• Percutaneous Electrical Nerve Field Stimulation (PENFS) (Neurostimulation)

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.

Participant Groups

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.

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic neuropathic pain: a single institution experience. [2018]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic headache: 60 cases and long-term follow-up. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

High-Frequency Supraorbital Nerve Stimulation With a Novel Wireless Minimally Invasive Device for Post-Traumatic Neuralgia: A Case Report. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for trigeminal neuralgia, trigeminal neuropathic pain, and persistent idiopathic facial pain. [2017]