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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Post-Concussion Syndrome; COVID Long-Haul
• Intervention / Treatment: 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)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa Ornelas; Phone Number: 714-509-8765; Email: elisa.ornelas@choc.org
• Study Contact Backup: Name: Jamie Janchoi; Phone Number: 714-509-8765; Email: jamie.janchoi@choc.org

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • CHOC Children's
      • Contact: Elisa Ornelas; Email: elisa.ornelas@choc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Neurostim Device; Patients in this group will receive the active devices for the initial 4 study weeks.	Device: percutaneous electrical nerve-field stimulation, PENFS; A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
Sham Comparator: Sham Neurostim Device; 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); 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.
Experimental: COVID Active Neurostim Device; Patients in this group will receive the active devices for the 6 study weeks.	Device: percutaneous electrical nerve-field stimulation, PENFS (COVID active device); A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthostatic Vitals	numerical number that determines blood pressure. Having a high blood pressure indicates worse outcome. Reading will be done by a provider.	8 weeks
Electrocardiography	Heart rate measurement- a recording of electrical signal from the heart to check for heart conditions. Reading will be done by a provider.	8 weeks
Pupillometry	Pupillometry: An eye assessment to measure pupil size and reactivity, reading will be done by a provider	8 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Orange County
• Collaborators: Innovative Health Solutions

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Syndrome; Post-Concussion Syndrome
• Other Study ID Numbers: 190667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes