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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2026 to Jan 2027
    v5
  2. Primary completion date: Jan 2025 to Dec 2025
    • Site contact updated
    v4
  3. Primary completion date: Jan 2024 to Jan 2025v3 Show 8 more changesShow less
    • Primary endpoints: 3 to 4
    • Enrollment target: 100 to 125
    • Study completion date: Dec 2024 to Dec 2026
    • Interventions: percutaneous electrical nerve-field stimulation, PENFS (Device), percutaneous electrical nerve-field stimulation, PENFS (sham device)… to percutaneous electrical nerve-field stimulation, PENFS (COVID active device) (Device), percutaneous electrical nerve-field stimulation…
    • Eligibility criteria expanded, about 87 words
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 132 words
    • Study arms: 2 to 3
  4. Primary completion date: Jan 2023 to Jan 2024
    • Study completion date: Feb 2023 to Dec 2024
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04978571
Lead Sponsor Children's Hospital of Orange County
Collaborators: Innovative Health Solutions
Conditions
(from sponsor)		 Post-Concussion Syndrome, COVID Long-Haul, COVID-19
Related terms COVID-19, Post-Acute COVID-19 Syndrome, Post-Concussion Syndrome
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov