COVID-19, COVID Long-Haul, Post-Concussion Syndrome
Conditions
Brief 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.
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.
Interventions
DEVICEpercutaneous electrical nerve-field stimulation, PENFS
A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
DEVICEpercutaneous 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.
DEVICEpercutaneous 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
Sponsors
Children's Hospital of Orange County
Innovative Health Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
Concussion: prospective, randomized-controlled treatment trial. COVID: prospective, open label, non-randomized-controlled treatment trial.
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Concussion: Inclusion Criteria: * 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
Exclusion criteria
* Seizure disorders * Significant developmental delay * Infection or severe dermatological condition of ear * Bleeding disorders * Implanted electrical device COVID: Inclusion Criteria * 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 You cannot participate in this study if you meet the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COGNIGRAM | 10 weeks | COGNIGRAM is a test prescribed by clinicians to measure cognitive function. |
| Immediate Post-Concussion Assessment | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functioning disability inventory | 8 weeks | 15 item, asking on functioning, higher score indicated worse outcome. |
| Patient-Reported Outcomes Measurement Information System- Anxiety | 8 weeks | 8 item questionnaire asking on anxiety level. Higher score indicates worse outcome. |
| Patient-Reported Outcomes Measurement Information System- Depression | 8 weeks | 8 item asking on depression, higher score indicated worse outcome |
| Covid-19 questionnaire | 10 weeks | 40-item asking Covid related symptoms and history. |
| Patient-Reported Outcomes Measurement Information System-Global health scales | 8 weeks | 7-item asking on general health, lower score indicates worse outcome |
| Abdominal Pain Index | 8 weeks | 4 item to rate abdominal pain. Higher score indicates having worse outcome. |
| Baxter Animated Retching Faces Nausea Scale | 8 weeks | rate on a 1-10 scale level of nausea. Higher score indicated feeling worse. |
| Children's Somatization inventory | 8 weeks | 23 item to rate symptoms, higher score indicates worse symptoms |
Countries
United States
Contacts
CONTACTPari Mokhtari
CONTACTJamie Janchoi
Outcome results
None listed