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New treatment option for Post-Concussion Syndrome
Official title Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
ClinicalTrials.gov ID: NCT04978571
What this study is testing
- What it's testing
- 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.
- Time commitment: about 10 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 18
You may be able to join if
- Concussion:
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Concussion:
- 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
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.