Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorChildren's Hospital of Orange County
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Seizure disorders
Significant developmental delay
Infection or severe dermatological condition of ear
Bleeding disorders
Trial design
Design model
Parallel
Treatments tested in this trial
percutaneous electrical nerve-field stimulation, PENFS
DeviceA 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)
DeviceA 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)
DeviceA novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
Treatment groups
125 Participants
are divided into 3 treatment groupsGroup A: Active Neurostim DeviceExperimental treatment 1 intervention
Group B: Sham Neurostim DeviceSham comparator 1 intervention
Group C: COVID Active Neurostim DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
8 weeks3
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.
Time frame
8 weeks4
COGNIGRAM
COGNIGRAM is a test prescribed by clinicians to measure cognitive function.
Time frame
10 weeksSecondary outcomes
1
Abdominal Pain Index
4 item to rate abdominal pain. Higher score indicates having worse outcome.
Time frame
8 weeks2
Baxter Animated Retching Faces Nausea Scale
rate on a 1-10 scale level of nausea. Higher score indicated feeling worse.
Time frame
8 weeks3
Children's Somatization inventory
23 item to rate symptoms, higher score indicates worse symptoms
Time frame
8 weeks4
Functioning disability inventory
15 item, asking on functioning, higher score indicated worse outcome.
Time frame
8 weeksOther outcomes
1
Orthostatic Vitals
numerical number that determines blood pressure. Having a high blood pressure indicates worse outcome. Reading will be done by a provider.
Time frame
8 weeks2
Electrocardiography
Heart rate measurement- a recording of electrical signal from the heart to check for heart conditions. Reading will be done by a provider.
Time frame
8 weeks3
Pupillometry
Pupillometry: An eye assessment to measure pupil size and reactivity, reading will be done by a provider
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Orange County
Lead sponsor
Innovative Health Solutions
Collaborator
Source ClinicalTrials.gov