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

Not Applicable

Recruiting

• Conditions: COVID Long-Haul; COVID-19; Post-Concussion Syndrome
• Interventions: Device: percutaneous electrical nerve-field stimulation, PENFS (sham device); Device: percutaneous electrical nerve-field stimulation, PENFS; Device: percutaneous electrical nerve-field stimulation, PENFS (COVID active device)

• Registration Number: NCT04978571
• Lead Sponsor: Children's Hospital of Orange County

Brief Summary

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

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 Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-07-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26
• Primary Completion: 2025-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Neurostim Device	percutaneous electrical nerve-field stimulation, PENFS (sham 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.
Active Neurostim Device	percutaneous electrical nerve-field stimulation, PENFS	Patients in this group will receive the active devices for the initial 4 study weeks.
COVID Active Neurostim Device	percutaneous electrical nerve-field stimulation, PENFS (COVID active device)	Patients in this group will receive the active devices for the 6 study weeks.

Primary Outcome Measures

Name	Time	Method
Immediate Post-Concussion Assessment	8 weeks	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.
Post-Concussion Symptom Scale	8 weeks	Post Concussion Symptom Scale- a 22 item questionnaire, rated on a 0-6 scale. Having a higher score indicates having worse symptom assessment.
COGNIGRAM	10 weeks	COGNIGRAM is a test prescribed by clinicians to measure cognitive function.
Balance Error Scoring Symptom	8 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHOC Children's; 🇺🇸 Orange, California, United States