Post-Concussion SyndromeNCT04978571
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
A study testing percutaneous electrical nerve-field stimulation, PENFS and percutaneous electrical nerve-field stimulation, PENFS (COVID active device) in people with Post-Concussion Syndrome and COVID Long-Haul, run by Children's Hospital of Orange County at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Post-Concussion Syndrome, COVID Long-Haul, COVID-19
- What is being tested?
- percutaneous electrical nerve-field stimulation, PENFS and percutaneous electrical nerve-field stimulation, PENFS (COVID active device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Seizure disorders
- Significant developmental delay
- Infection or severe dermatological condition of ear
- Bleeding disorders
- Implanted electrical device
- COVID:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CHOC Children's
Orange, California, 92868
Pari Mokhtari, pari.mokhtari@choc.org
About this study
Official title: A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
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.
Read the 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.
- Conditions
- Post-Concussion Syndrome, COVID Long-Haul, COVID-19
- Being tested
- percutaneous electrical nerve-field stimulation, PENFS, percutaneous electrical nerve-field stimulation, PENFS (sham device), percutaneous electrical nerve-field stimulation, PENFS (COVID active device)
- Medical subject headings
- Post-Concussion Syndrome, Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous electrical nerve-field stimulation, PENFSDevice
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 group | Role | What they receive |
|---|---|---|
| Active Neurostim Device | Experimental | Patients in this group will receive the active devices for the initial 4 study weeks. Receives: Device: percutaneous electrical nerve-field stimulation, PENFS |
| Sham Neurostim Device | Sham comparator | 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. Receives: Device: percutaneous electrical nerve-field stimulation, PENFS (sham device) |
| COVID Active Neurostim Device | Experimental | Patients in this group will receive the active devices for the 6 study weeks. Receives: Device: percutaneous electrical nerve-field stimulation, PENFS (COVID active device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
COGNIGRAM
COGNIGRAM is a test prescribed by clinicians to measure cognitive function.
Measured: 10 weeks
Secondary outcomes (8)
Abdominal Pain Index
4 item to rate abdominal pain. Higher score indicates having worse outcome.
Measured: 8 weeks
Baxter Animated Retching Faces Nausea Scale
rate on a 1-10 scale level of nausea. Higher score indicated feeling worse.
Measured: 8 weeks
Children's Somatization inventory
23 item to rate symptoms, higher score indicates worse symptoms
Measured: 8 weeks
Functioning disability inventory
15 item, asking on functioning, higher score indicated worse outcome.
Measured: 8 weeks
Patient-Reported Outcomes Measurement Information System- Anxiety
8 item questionnaire asking on anxiety level. Higher score indicates worse outcome.
Measured: 8 weeks
Patient-Reported Outcomes Measurement Information System- Depression
8 item asking on depression, higher score indicated worse outcome
Measured: 8 weeks
Patient-Reported Outcomes Measurement Information System-Global health scales
7-item asking on general health, lower score indicates worse outcome
Measured: 8 weeks
Covid-19 questionnaire
40-item asking Covid related symptoms and history.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Feb 2021
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Concussion: prospective, randomized-controlled treatment trial. COVID: prospective, open label, non-randomized-controlled treatment trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashish Chogle, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978571
- Sponsor's protocol ID
- 190667
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
- ClinicalTrials.gov ID
- NCT04978571
- Acronym / sponsor ID
- 190667
- Conditions
- Post-Concussion Syndrome, COVID Long-Haul, COVID-19
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Concussion: prospective, randomized-controlled treatment trial. COVID: prospective, open label, non-randomized-controlled treatment trial.
| Arm | Type | Receives |
|---|---|---|
| Active Neurostim Device | Experimental | Device: percutaneous electrical nerve-field stimulation, PENFSPatients in this group will receive the active devices for the initial 4 study weeks. |
| Sham Neurostim Device | Sham comparator | Device: percutaneous electrical nerve-field stimulation, PENFS (sham 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. |
| COVID Active Neurostim Device | Experimental | Device: percutaneous electrical nerve-field stimulation, PENFS (COVID active device)Patients in this group will receive the active devices for the 6 study weeks. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (6 listed)
- Seizure disorders
- Significant developmental delay
- Infection or severe dermatological condition of ear
- Bleeding disorders
- Implanted electrical device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous electrical nerve-field stimulation, PENFSA novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear | Device | Active Neurostim Device |
| 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. | Device | Sham Neurostim Device |
| 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 | Device | COVID Active Neurostim Device |
Primary outcome
Immediate Post-Concussion Assessment
Time frame: 8 weeks
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.
Post-Concussion Symptom Scale
Time frame: 8 weeks
Post Concussion Symptom Scale- a 22 item questionnaire, rated on a 0-6 scale. Having a higher score indicates having worse symptom assessment.
Balance Error Scoring Symptom
Time frame: 8 weeks
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.
COGNIGRAM
Time frame: 10 weeks
COGNIGRAM is a test prescribed by clinicians to measure cognitive function.
8 secondary outcomes
Abdominal Pain Index
Time frame: 8 weeks
Baxter Animated Retching Faces Nausea Scale
Time frame: 8 weeks
Children's Somatization inventory
Time frame: 8 weeks
Functioning disability inventory
Time frame: 8 weeks
Patient-Reported Outcomes Measurement Information System- Anxiety
Time frame: 8 weeks
Patient-Reported Outcomes Measurement Information System- Depression
Time frame: 8 weeks
Patient-Reported Outcomes Measurement Information System-Global health scales
Time frame: 8 weeks
Covid-19 questionnaire
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Syndrome
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Move&Connect: A Program for Youth With Concussion and Their Caregivers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous electrical nerve-field stimulation, PENFS and percutaneous electrical nerve-field stimulation, PENFS (COVID active device) in people with Post-Concussion Syndrome and COVID Long-Haul, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pari Mokhtari (714-509-8765, pari.mokhtari@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Post-Concussion Assessment (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.