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| Name | Class |
|---|---|
| Innovative Health Solutions | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Neurostim Device | Experimental | Patients in this group will receive the active devices for the initial 4 study weeks. |
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| 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. |
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| COVID Active Neurostim Device | Experimental | Patients in this group will receive the active devices for the 6 study weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 8 weeks |
| COGNIGRAM | COGNIGRAM is a test prescribed by clinicians to measure cognitive function. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain Index | 4 item to rate abdominal pain. Higher score indicates having worse outcome. | 8 weeks |
| Baxter Animated Retching Faces Nausea Scale | rate on a 1-10 scale level of nausea. Higher score indicated feeling worse. |
| Measure | Description | Time Frame |
|---|---|---|
| Orthostatic Vitals | numerical number that determines blood pressure. Having a high blood pressure indicates worse outcome. Reading will be done by a provider. | 8 weeks |
| Electrocardiography | Heart rate measurement- a recording of electrical signal from the heart to check for heart conditions. Reading will be done by a provider. |
Concussion:
Inclusion Criteria:
Exclusion Criteria:
COVID:
Inclusion Criteria
You cannot participate in this study if you meet the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pari Mokhtari | Contact | 714-509-8765 | pari.mokhtari@choc.org | |
| Jamie Janchoi | Contact | 714-509-8765 | jamie.janchoi@choc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHOC Children's | Recruiting | Orange | California | 92868 | United States |
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Concussion: prospective, randomized-controlled treatment trial. COVID: prospective, open label, non-randomized-controlled treatment trial.
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Concussion: After study completion, a designated member of the study will disclose study group. This designated member will not have direct contact with study participants during their participation.
COVID: open label
| 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 |
|
| 8 weeks |
| Children's Somatization inventory | 23 item to rate symptoms, higher score indicates worse symptoms | 8 weeks |
| Functioning disability inventory | 15 item, asking on functioning, higher score indicated worse outcome. | 8 weeks |
| Patient-Reported Outcomes Measurement Information System- Anxiety | 8 item questionnaire asking on anxiety level. Higher score indicates worse outcome. | 8 weeks |
| Patient-Reported Outcomes Measurement Information System- Depression | 8 item asking on depression, higher score indicated worse outcome | 8 weeks |
| Patient-Reported Outcomes Measurement Information System-Global health scales | 7-item asking on general health, lower score indicates worse outcome | 8 weeks |
| Covid-19 questionnaire | 40-item asking Covid related symptoms and history. | 10 weeks |
| 8 weeks |
| Pupillometry | Pupillometry: An eye assessment to measure pupil size and reactivity, reading will be done by a provider | 8 weeks |
| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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