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

NCT04978571 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-03-18

No results posted yet for this 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.

Conditions

  • Post-Concussion Syndrome
  • COVID Long-Haul
  • COVID-19

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

Sponsors & Collaborators

  • Innovative Health Solutions

    collaborator INDUSTRY

  • Children's Hospital of Orange County

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04978571 on ClinicalTrials.gov