Neurostimulation for Paroxysmal Sympathetic Hyperactivity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new device called PENFS, which is worn on the ear and sends electrical signals to help control symptoms in children with severe brain injuries who suffer from PSH. The device aims to calm the overactive nervous system, potentially reducing the need for multiple medications and their side effects.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.
Is percutaneous electrical nerve field stimulation (PENFS) safe for humans?
How is the treatment for Paroxysmal Sympathetic Hyperactivity using PENFS different from other treatments?
What data supports the effectiveness of the treatment Percutaneous Electrical Nerve Field Stimulation (PENFS) for Paroxysmal Sympathetic Hyperactivity?
Research on similar treatments, like electrical vagus nerve stimulation, shows promise in managing conditions with autonomic imbalance, such as heart failure, by reducing excessive sympathetic activity. This suggests that PENFS might also help in conditions like Paroxysmal Sympathetic Hyperactivity by modulating nerve activity.1011121314
Who Is on the Research Team?
Binod Balakrishnan, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
This trial is for children aged 2-17 with moderate to severe PSH due to brain injury, who are not fully conscious (Glasgow Coma Scale < 15). It's not suitable for kids with ear issues, uncontrollable seizures, other implants like pacemakers, or those under 2 years old.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Application of the PENFS device over the external ear for continuous 120-hour periods
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PENFS
PENFS is already approved in United States for the following indications:
- Functional abdominal pain associated with irritable bowel syndrome in adolescents 11-18 years of age
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Advancing a Healthier Wisconsin Endowment (AHW)
Collaborator
Children's Wisconsin
Collaborator