Clinical trial NCT04978571: Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Official title: A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Concussion Syndrome
COVID Long-Haul
COVID-19
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
Collaborators: name: Innovative Health Solutions
First posted: 2021-07-27
Enrollment: 125
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Concussion: prospective, randomized-controlled treatment trial. COVID: prospective, open label, non-randomized-controlled treatment trial.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Immediate Post-Concussion Assessment
timeFrame: 8 weeks
measure: Post-Concussion Symptom Scale
timeFrame: 8 weeks
measure: Balance Error Scoring Symptom
timeFrame: 8 weeks
measure: COGNIGRAM
timeFrame: 10 weeks
Secondary outcomes:
measure: Abdominal Pain Index
timeFrame: 8 weeks
measure: Baxter Animated Retching Faces Nausea Scale
timeFrame: 8 weeks
measure: Children's Somatization inventory
timeFrame: 8 weeks
measure: Functioning disability inventory
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System- Anxiety
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System- Depression
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System-Global health scales
timeFrame: 8 weeks
measure: Covid-19 questionnaire
timeFrame: 10 weeks
Other outcomes:
measure: Orthostatic Vitals
timeFrame: 8 weeks
measure: Electrocardiography
timeFrame: 8 weeks
measure: Pupillometry
timeFrame: 8 weeks
Locations:
city: Orange
country: United States
facility: CHOC Children's
state: California
Study officials:
References: