Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

COVID-19 Clinical Trial

Official title:

A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04978571
• Other study ID #: 190667
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Children's Hospital of Orange County
• Contact: Elisa Ornelas
• Phone: 714-509-8765
• Email: elisa.ornelas[@]choc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Post-Concussion Syndrome
• Syndrome

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
United States	CHOC Children's	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Orange County	Innovative Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Orthostatic Vitals	numerical number that determines blood pressure. Having a high blood pressure indicates worse outcome. Reading will be done by a provider.	8 weeks
Other	Electrocardiography	Heart rate measurement- a recording of electrical signal from the heart to check for heart conditions. Reading will be done by a provider.	8 weeks
Other	Pupillometry	Pupillometry: An eye assessment to measure pupil size and reactivity, reading will be done by a provider	8 weeks
Primary	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
Primary	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
Primary	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
Primary	COGNIGRAM	COGNIGRAM is a test prescribed by clinicians to measure cognitive function.	10 weeks
Secondary	Abdominal Pain Index	4 item to rate abdominal pain. Higher score indicates having worse outcome.	8 weeks
Secondary	Baxter Animated Retching Faces Nausea Scale	rate on a 1-10 scale level of nausea. Higher score indicated feeling worse.	8 weeks
Secondary	Children's Somatization inventory	23 item to rate symptoms, higher score indicates worse symptoms	8 weeks
Secondary	Functioning disability inventory	15 item, asking on functioning, higher score indicated worse outcome.	8 weeks
Secondary	Patient-Reported Outcomes Measurement Information System- Anxiety	8 item questionnaire asking on anxiety level. Higher score indicates worse outcome.	8 weeks
Secondary	Patient-Reported Outcomes Measurement Information System- Depression	8 item asking on depression, higher score indicated worse outcome	8 weeks
Secondary	Patient-Reported Outcomes Measurement Information System-Global health scales	7-item asking on general health, lower score indicates worse outcome	8 weeks
Secondary	Covid-19 questionnaire	40-item asking Covid related symptoms and history.	10 weeks