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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
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.
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
CHOC Children's
Orange, California, United States
RECRUITINGImmediate 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 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.
Time frame: 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.
Time frame: 8 weeks
COGNIGRAM
COGNIGRAM is a test prescribed by clinicians to measure cognitive function.
Time frame: 10 weeks
Abdominal Pain Index
4 item to rate abdominal pain. Higher score indicates having worse outcome.
Time frame: 8 weeks
Baxter Animated Retching Faces Nausea Scale
rate on a 1-10 scale level of nausea. Higher score indicated feeling worse.
Time frame: 8 weeks
Children's Somatization inventory
23 item to rate symptoms, higher score indicates worse symptoms
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Functioning disability inventory
15 item, asking on functioning, higher score indicated worse outcome.
Time frame: 8 weeks
Patient-Reported Outcomes Measurement Information System- Anxiety
8 item questionnaire asking on anxiety level. Higher score indicates worse outcome.
Time frame: 8 weeks
Patient-Reported Outcomes Measurement Information System- Depression
8 item asking on depression, higher score indicated worse outcome
Time frame: 8 weeks
Patient-Reported Outcomes Measurement Information System-Global health scales
7-item asking on general health, lower score indicates worse outcome
Time frame: 8 weeks
Covid-19 questionnaire
40-item asking Covid related symptoms and history.
Time frame: 10 weeks