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RECRUITING
NCT04978571
NA

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

Sponsor: Children's Hospital of Orange County

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

11 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2021-02-01

Completion Date

2027-01

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

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

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.

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

Locations (1)

CHOC Children's

Orange, California, United States