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Neurostimulation

PENFS for Post-Concussion Syndrome

N/A
Recruiting
Research Sponsored by Children's Hospital of Orange County
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of Post-Concussion Syndrome
Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial is testing whether a device that sends electrical signals to the ear can help treat children with pain and concussion symptoms.

Who is the study for?
This trial is for children who have been diagnosed with Post-Concussion Syndrome and have had symptoms for at least three months without other explanations. It's open to families that speak English or Spanish.Check my eligibility
What is being tested?
The study tests Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS), a neurostimulation device, on children with pain and post-concussion symptoms, as well as those with lingering post-COVID-19 issues.See study design
What are the potential side effects?
While the document doesn't specify side effects, similar nerve stimulation treatments can sometimes cause discomfort at the site of application, headache, dizziness or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Post-Concussion Syndrome.
Select...
I have had concussion symptoms for over 3 months with no other cause.
Select...
My child has had COVID-19 symptoms for over 3 months with no other explanation for their condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Balance Error Scoring Symptom
COGNIGRAM
Immediate Post-Concussion Assessment
+1 more
Secondary outcome measures
Abdominal Pain Index
Baxter Animated Retching Faces Nausea Scale
Children's Somatization inventory
+5 more
Other outcome measures
Electrocardiography
Orthostatic Vitals
Pupillometry

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: COVID Active Neurostim DeviceExperimental Treatment1 Intervention
Patients in this group will receive the active devices for the 6 study weeks.
Group II: Active Neurostim DeviceExperimental Treatment1 Intervention
Patients in this group will receive the active devices for the initial 4 study weeks.
Group III: Sham Neurostim DevicePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Innovative Health SolutionsUNKNOWN
3 Previous Clinical Trials
83 Total Patients Enrolled
Children's Hospital of Orange CountyLead Sponsor
32 Previous Clinical Trials
4,809 Total Patients Enrolled
1 Trials studying Post-Concussion Syndrome
130 Patients Enrolled for Post-Concussion Syndrome

Media Library

Percutaneous Electrical Nerve Field Stimulation (PENFS) (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04978571 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this examination still recruiting participants?

"The information on clinicaltrials.gov confirms that this trial is actively searching for patients, having been published on February 1st 2021 and last updated on July 23rd 2021."

Answered by AI

What is the aim of this research project?

"The primary endpoint of this 8-week trial is the Post-Concussion Symptom Scale, while secondary objectives include the Children's Somatization Inventory (23 items to rate symptoms; higher scores indicate worse outcomes), Patient-Reported Outcomes Measurement Information System depression survey (8 questions regarding one’s mental state; increased scores reflect a greater burden of depressive symptoms) and the Baxter Animated Retching Faces Nausea Scale (assesses nausea on a 1-10 scale with 10 representing highest intensity)."

Answered by AI

Is eligibility available to participate in this research program?

"This clinical trial is open to 100 minors aged between 12 and 18 who have been clinically diagnosed with Post-Concussion Syndrome. To be eligible, participants must demonstrate that they have suffered from Post-Concussion Symptoms for a minimum of 3 months without another explanation, alongside the ability to communicate in English or Spanish."

Answered by AI

How many subjects are being included in this study?

"Correct. According to the details shared on clinicaltrials.gov, this research project has been opened for recruitment since February 1st 2021 and was last modified on July 23rd 2021. This medical trial is looking to enrol 100 volunteers at a single site."

Answered by AI

Does this clinical trial accept participants above the age of forty?

"For this particular medical study, participants must meet the age requirement of 12 to 18 years old. Currently, 385 studies are available for minors under 18 and 994 studies specifically designed for seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Ashish Chogle 2021. "Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978571.
All > Concussion > Coronavirus
~21 spots leftby Jan 2025
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