Using a nerve stimulation device to treat severe sympathetic hyperactivity in children
Percutaneous Neurostimulation for Treatment of Paroxysmal Sympathetic Hyperactivity in Children With Acute Severe Brain Injury
This study is testing a new nerve stimulation device to see if it can help children aged 2-17 with severe symptoms from brain injuries feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05343988 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a novel non-invasive device called Percutaneous Electrical Nerve Field Stimulation (PENFS) to treat Paroxysmal Sympathetic Hyperactivity (PSH) in children aged 2-17 who have suffered from acute severe brain injury. PSH is characterized by debilitating symptoms such as rapid heart rate and high blood pressure, which can lead to further complications. The study aims to assess the effectiveness of PENFS in reducing these symptoms and improving the quality of life for affected children. Participants will be evaluated using a scoring system to determine the severity of their condition before and after treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-17 years who exhibit moderate to severe symptoms of PSH due to acute severe brain injury.
Not a fit: Patients under 2 years of age, those with ear deformities, severe dermatitis, intractable seizures, or existing implantable devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-drug treatment option that alleviates severe symptoms of PSH, reducing the need for multiple medications and their associated side effects.
How similar studies have performed: While the use of nerve stimulation for similar conditions is promising, this specific application of PENFS for PSH in children is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children 2-17 years age with PSH due to ASBI * PSH severity score \> 6 (moderate severity) * Glasgow Coma Scale \< 15 Exclusion Criteria: * age \< 2 years (small ears thus less surface area to apply the leads) * ear deformity or severe dermatitis of ear lobes, * intractable seizures, heart block, patients with other implantable devices (cardiac pacemaker, vagal nerve stimulator, etc. * known pregnancy
Where this trial is running
Milwaukee, Wisconsin
- Children's Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Binod Balakrishnan, MD — Medical College of Wisconsin
- Study coordinator: Binod Balakrishnan, MD
- Email: bbalakris@mcw.edu
- Phone: 4142663360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.