Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Neurostim Device Patients in this group will receive the active devices for the initial 4 study weeks. |
Device: percutaneous 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
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| Sham Comparator: Sham Neurostim 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- Patient-Reported Outcomes Measurement Information System-Global health scales [8 weeks]
7-item asking on general health, lower score indicates worse outcome
Other Outcome Measures
- Orthostatic Vitals [8 weeks]
numerical number that determines blood pressure. Having a high blood pressure indicates worse outcome. Reading will be done by a provider.
- Electrocardiography [8 weeks]
Heart rate measurement- a recording of electrical signal from the heart to check for heart conditions. Reading will be done by a provider.
- Pupillometry [8 weeks]
Pupillometry: An eye assessment to measure pupil size and reactivity, reading will be done by a provider
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of Post-Concussion Syndrome
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Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms
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English and Spanish-speaking families
Exclusion Criteria:
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Seizure disorders
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Significant developmental delay
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Infection or severe dermatological condition of ear
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Bleeding disorders
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Implanted electrical device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHOC Children's | Orange | California | United States | 92868 |
Sponsors and Collaborators
- Children's Hospital of Orange County
- Innovative Health Solutions
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 190667