Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: percutaneous electrical nerve-field stimulation, PENFS, percutaneous electrical nerve-field stimulation, PENFS (sham device), percutaneous electrical nerve-field stimulation, PENFS (COVID active device).
- Who it may be relevant to
- Registry conditions: Post-Concussion Syndrome, COVID Long-Haul, COVID-19. Basic parameters: 11 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Overview
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.
Detailed description
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. Patient will be offered a Neurostim device. This device is placed on the outer ear through tiny needles. Since this is a randomized trial, patients may receive an active (experiment) or nonactive (control) Neurostim device. However, the nonactive control Neurostim device group will be given the option to receive an active device after the initial study procedures. The experiment group may be in this study up to 8 weeks and the control group may be in this study up to 12 weeks. The control group will have 4 additional weeks due to the transition to an active device following the first 8 weeks. The device is worn weekly for 4 weeks. Each device is worn for 5 consecutive days for the full 24 hours. The participant will be able to easily take the device off on the 6th day. Study procedures include: Neurological testing- a balance test and computerized neurological standard testing, Cardiology testing- electrocardiogram for heart rate variability (heart electrical pulse test), a pupilometer (eye) test, and parent/child questionnaires. You may benefit from this research, but there is no guarantee that being in this study will help you.
Patients in the COVID arm will be offered 6 placements of Neurostim devices. This device is placed on the outer ear through tiny needles. Patients in this arm will not be randomized, all patients will receive active devices. This group will be in the study for up to 10 weeks. The device is worn weekly for 6 weeks. Each device is worn for 5 consecutive days for the full 24 hours. The patient will be able to remove the device on the 6th day. Study procedures include: Neurological testing called Cognigram to measure cognitive functioning and parent/child questionnaires. After 6 weeks of device placements, parent and child will complete a 1-week and 1-questionnaires. You may benefit from this research, but there is no guarantee that being in this study will help you.
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
Primary outcome measures
- Immediate Post-Concussion Assessment [Time frame: 8 weeks]
- Post-Concussion Symptom Scale [Time frame: 8 weeks]
- Balance Error Scoring Symptom [Time frame: 8 weeks]
- COGNIGRAM [Time frame: 10 weeks]
Secondary outcome measures (8)
- Abdominal Pain Index [Time frame: 8 weeks]
- Baxter Animated Retching Faces Nausea Scale [Time frame: 8 weeks]
- Children's Somatization inventory [Time frame: 8 weeks]
- Functioning disability inventory [Time frame: 8 weeks]
- Patient-Reported Outcomes Measurement Information System- Anxiety [Time frame: 8 weeks]
- Patient-Reported Outcomes Measurement Information System- Depression [Time frame: 8 weeks]
- Patient-Reported Outcomes Measurement Information System-Global health scales [Time frame: 8 weeks]
- Covid-19 questionnaire [Time frame: 10 weeks]
Eligibility criteria
Concussion:
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- CHOC Children's — Orange
Identifiers
NCT: NCT04978571 · 190667