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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

Locations
United States
California
CHOC Children's
RECRUITING
Orange
Contact Information
Primary
Pari Mokhtari
pari.mokhtari@choc.org
714-509-8765
Backup
Jamie Janchoi
jamie.janchoi@choc.org
714-509-8765
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 125
Treatments
Experimental: Active Neurostim Device
Patients in this group will receive the active devices for the initial 4 study weeks.
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.
Experimental: COVID Active Neurostim Device
Patients in this group will receive the active devices for the 6 study weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Innovative Health Solutions
Leads: Children's Hospital of Orange County

This content was sourced from clinicaltrials.gov