Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
1 other identifier
interventional
125
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 18, 2026
March 1, 2026
5.8 years
April 21, 2021
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Immediate Post-Concussion Assessment
With the Immediate Post-Concussion Assessment, percentiles indicate functioning assessment after a concussion. Having a higher score on this assessment implies having a worse outcome assessment.
8 weeks
Post-Concussion Symptom Scale
Post Concussion Symptom Scale- a 22 item questionnaire, rated on a 0-6 scale. Having a higher score indicates having worse symptom assessment.
8 weeks
Balance Error Scoring Symptom
Balance Error Scoring Symptom- a balance test conducted in person. Patient is asked to do a 3 poses on the floor and 3 poses standing on a foam and asked to stand still. The amount of errors will be counted for the times the patient moves. The higher the errors, means patient does not have a well-balance.
8 weeks
COGNIGRAM
COGNIGRAM is a test prescribed by clinicians to measure cognitive function.
10 weeks
Secondary Outcomes (8)
Abdominal Pain Index
8 weeks
Baxter Animated Retching Faces Nausea Scale
8 weeks
Children's Somatization inventory
8 weeks
Functioning disability inventory
8 weeks
Patient-Reported Outcomes Measurement Information System- Anxiety
8 weeks
- +3 more secondary outcomes
Other Outcomes (3)
Orthostatic Vitals
8 weeks
Electrocardiography
8 weeks
Pupillometry
8 weeks
Study Arms (3)
Active Neurostim Device
EXPERIMENTALPatients in this group will receive the active devices for the initial 4 study weeks.
Sham Neurostim Device
SHAM COMPARATORPatients in this group will receive the sham devices for the initial 4 study weeks. However, they will be offered the 4 active devices after.
COVID Active Neurostim Device
EXPERIMENTALPatients in this group will receive the active devices for the 6 study weeks.
Interventions
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
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.
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- Seizure disorders
- Significant developmental delay
- Infection or severe dermatological condition of ear
- Bleeding disorders
- Implanted electrical device
- COVID:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Orange Countylead
- Innovative Health Solutionscollaborator
Study Sites (1)
CHOC Children's
Orange, California, 92868, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Concussion: After study completion, a designated member of the study will disclose study group. This designated member will not have direct contact with study participants during their participation. COVID: open label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 21, 2021
First Posted
July 27, 2021
Study Start
February 1, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share