Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
NCT ID: NCT04978571
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2021-02-01
2026-12-31
Brief Summary
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An additional purpose of this study is to demonstrate that PENFS improves functioning in children with post Covid-19 symptoms.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
COVID: open label
Study Groups
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Active Neurostim Device
Patients in this group will receive the active devices for the initial 4 study weeks.
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
Sham Neurostim Device
Patients in this group will receive the sham devices for the initial 4 study weeks. However, they will be offered the 4 active devices after.
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.
COVID Active Neurostim Device
Patients in this group will receive the active devices for the 6 study weeks.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms
* English and Spanish-speaking families
* 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
Exclusion Criteria
* Significant developmental delay
* Infection or severe dermatological condition of ear
* Bleeding disorders
* Implanted electrical device
COVID:
* 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.
11 Years
18 Years
ALL
No
Sponsors
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Innovative Health Solutions
INDUSTRY
Children's Hospital of Orange County
OTHER
Responsible Party
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Ashish Chogle
Principal Investigator
Locations
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CHOC Children's
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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190667
Identifier Type: -
Identifier Source: org_study_id
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