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

Phase

N/A

Condition

Brain Injury

Covid-19

Treatment

percutaneous electrical nerve-field stimulation, PENFS

percutaneous electrical nerve-field stimulation, PENFS (COVID active device)

percutaneous electrical nerve-field stimulation, PENFS (sham device)

Clinical Study ID

NCT04978571

190667

Ages 11-18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Concussion:

Inclusion Criteria:

Clinical diagnosis of Post-Concussion Syndrome
Post-Concussion Symptoms for at least 3 months along with lack of other explanationfor their symptoms
English and Spanish-speaking families

Exclusion

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 3months 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 dermatologicalcondition of ear, bleeding disorders, or having any implanted electrical device willbe excluded.
Are not able to attend Friday appointments for the Neurostim placements.

Study Design

percutaneous electrical nerve-field stimulation, PENFS

February 01, 2021

December 31, 2026

Study 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.

Connect with a study center

CHOC Children's
Orange, California 92868
United States
Active - Recruiting

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