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

Part of paid clinical trials in Orange, California.

Sponsor
Children's Hospital of Orange County
Study ID
NCT04978571
Status
Recruiting
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Conditions

  • COVID Long-Haul
  • COVID-19
  • Post-Concussion Syndrome

Eligibility Criteria

Sex
ALL
Age
11 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • percutaneous electrical nerve-field stimulation, PENFS — DEVICE
    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) — 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) — DEVICE
    A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Neurostim Device
    Patients in this group will receive the active devices for the initial 4 study weeks.
  • Sham Comparator: 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.
  • Experimental: COVID Active Neurostim Device
    Patients in this group will receive the active devices for the 6 study weeks.

Primary Outcome Measure

Immediate Post-Concussion Assessment [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CHOC Children'sOrangeCalifornia92868
Pari Mokhtari
[email protected]

Find similar trials in Orange, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
CHOC Children's· Orange, CA

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