Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

Study Overview
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Brief Summary
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The purpose of this study is to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms. An additional purpose of this study is to demonstrate that PENFS improves functioning in children with post Covid-19 symptoms.

Detailed Description
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The purpose of this study is to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms. Patient will be offered a Neurostim device. This device is placed on the outer ear through tiny needles. Since this is a randomized trial, patients may receive an active (experiment) or nonactive (control) Neurostim device. However, the nonactive control Neurostim device group will be given the option to receive an active device after the initial study procedures. The experiment group may be in this study up to 8 weeks and the control group may be in this study up to 12 weeks. The control group will have 4 additional weeks due to the transition to an active device following the first 8 weeks. The device is worn weekly for 4 weeks. Each device is worn for 5 consecutive days for the full 24 hours. The participant will be able to easily take the device off on the 6th day. Study procedures include: Neurological testing- a balance test and computerized neurological standard testing, Cardiology testing- electrocardiogram for heart rate variability (heart electrical pulse test), a pupilometer (eye) test, and parent/child questionnaires. You may benefit from this research, but there is no guarantee that being in this study will help you. Patients in the COVID arm will be offered 6 placements of Neurostim devices. This device is placed on the outer ear through tiny needles. Patients in this arm will not be randomized, all patients will receive active devices. This group will be in the study for up to 10 weeks. The device is worn weekly for 6 weeks. Each device is worn for 5 consecutive days for the full 24 hours. The patient will be able to remove the device on the 6th day. Study procedures include: Neurological testing called Cognigram to measure cognitive functioning and parent/child questionnaires. After 6 weeks of device placements, parent and child will complete a 1-week and 1-questionnaires. You may benefit from this research, but there is no guarantee that being in this study will help you.

Official Title
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A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

Conditions
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Post-Concussion Syndrome, COVID Long-Haul, COVID-19

Intervention / Treatment
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* Device: percutaneous electrical nerve-field stimulation, PENFS
* Device: percutaneous electrical nerve-field stimulation, PENFS (sham device)
* Device: percutaneous electrical nerve-field stimulation, PENFS (COVID active device)


Participation Criteria
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Eligibility Criteria
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Concussion: Inclusion Criteria: Clinical diagnosis of Post-Concussion Syndrome Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms English and Spanish-speaking families Exclusion Criteria: Seizure disorders Significant developmental delay Infection or severe dermatological condition of ear Bleeding disorders Implanted electrical device COVID: Inclusion Criteria Child is in between the ages 11-18 Child is present at CHOC Neurology clinic post covid-19 symptoms of more than 3 months duration along with lack of other explanation for their symptoms English-speaking and Spanish-speaking families You cannot participate in this study if you meet the following exclusion criteria: Children with significant developmental delay, infection or severe dermatological condition of ear, bleeding disorders, or having any implanted electrical device will be excluded. Are not able to attend Friday appointments for the Neurostim placements.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Concussion: prospective, randomized-controlled treatment trial. COVID: prospective, open label, non-randomized-controlled treatment trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Neurostim Device<br>Patients in this group will receive the active devices for the initial 4 study weeks. | Device: percutaneous electrical nerve-field stimulation, PENFS<br>* A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear<br>|
| Sham Comparator: Sham Neurostim Device<br>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. | Device: percutaneous electrical nerve-field stimulation, PENFS (sham device)<br>* A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear. The sham device will not deliver field stimulation to the ear.<br>|
| Experimental: COVID Active Neurostim Device<br>Patients in this group will receive the active devices for the 6 study weeks. | Device: percutaneous electrical nerve-field stimulation, PENFS (COVID active device)<br>* A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate Post-Concussion Assessment | With the Immediate Post-Concussion Assessment, percentiles indicate functioning assessment after a concussion. Having a higher score on this assessment implies having a worse outcome assessment. | 8 weeks | 
| Post-Concussion Symptom Scale | Post Concussion Symptom Scale- a 22 item questionnaire, rated on a 0-6 scale. Having a higher score indicates having worse symptom assessment. | 8 weeks | 
| Balance Error Scoring Symptom | Balance Error Scoring Symptom- a balance test conducted in person. Patient is asked to do a 3 poses on the floor and 3 poses standing on a foam and asked to stand still. The amount of errors will be counted for the times the patient moves. The higher the errors, means patient does not have a well-balance. | 8 weeks | 
| COGNIGRAM | COGNIGRAM is a test prescribed by clinicians to measure cognitive function. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Pain Index | 4 item to rate abdominal pain. Higher score indicates having worse outcome. | 8 weeks | 
| Baxter Animated Retching Faces Nausea Scale | rate on a 1-10 scale level of nausea. Higher score indicated feeling worse. | 8 weeks | 
| Children's Somatization inventory | 23 item to rate symptoms, higher score indicates worse symptoms | 8 weeks | 
| Functioning disability inventory | 15 item, asking on functioning, higher score indicated worse outcome. | 8 weeks | 
| Patient-Reported Outcomes Measurement Information System- Anxiety | 8 item questionnaire asking on anxiety level. Higher score indicates worse outcome. | 8 weeks | 
| Patient-Reported Outcomes Measurement Information System- Depression | 8 item asking on depression, higher score indicated worse outcome | 8 weeks | 
| Patient-Reported Outcomes Measurement Information System-Global health scales | 7-item asking on general health, lower score indicates worse outcome | 8 weeks | 
| Covid-19 questionnaire | 40-item asking Covid related symptoms and history. | 10 weeks |