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Neurostimulation

Neurostimulation for Paroxysmal Sympathetic Hyperactivity

N/A
Recruiting
Led By Binod Balakrishnan, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PSH severity score > 6 (moderate severity)
Children 2-17 years age with PSH due to ASBI
Must not have
Ear deformity or severe dermatitis of ear lobes
Intractable seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24hours, 25-48hours, 49-72hours, 73-96hours, 97-120hours
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
The study tests a non-drug treatment called PENFS. This device is applied to the ear and may calm overactive nervous systems in kids with PSH by stimulating nerve activity that can relax the body.
What are the potential side effects?
While specific side effects of PENFS aren't detailed here, similar devices can cause local irritation at the site of application and potential discomfort from electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain severity is more than moderate.
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My child is between 2-17 years old and has PSH due to ASBI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an ear deformity or severe skin irritation on my ear lobes.
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I have seizures that medication cannot control.
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I am under 2 years old.
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I have a heart block.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24hours, 25-48hours, 49-72hours, 73-96hours, 97-120hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24hours, 25-48hours, 49-72hours, 73-96hours, 97-120hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Capturing at least 80 percent of scoring events to assess pediatric Paroxysmal Sympathetic Hyperactivity (PSH) symptoms using the Clinical Feature Severity (CFS) scoring tool
Device tolerability for those children enrolled with acute severe brain injury (ASBI) and Paroxysmal Sympathetic Hyperactivity (PSH) to use the Percutaneous Electrical Nerve Field Stimulation (PENFS) device for treatment
Study retention for those children enrolled with acute severe brain injury (ASBI) and Paroxysmal Sympathetic Hyperactivity (PSH) to use the Percutaneous Electrical Nerve Field Stimulation (PENFS) device for treatment
+1 more
Secondary study objectives
Measure a change in maintenance and rescue medication use for treatment of PSH
Measure pupil size (mm) to determine the change in autonomic response
Measure pupil's constriction velocity (mm/sec) to determine the change in autonomic response
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Percutaneous Electrical Nerve Field Stimulation (PENFS) device applicationExperimental Treatment1 Intervention
The peripheral neurostimulator, PENFS device, will be placed over the external ear of enrolled patients. The device will continuously stay in place for 120 hours.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Paroxysmal Sympathetic Hyperactivity (PSH) aim to modulate the autonomic nervous system to balance the excessive sympathetic activity. The Percutaneous Electrical Nerve Field Stimulation (PENFS) device, for instance, increases parasympathetic activity by stimulating the vagus nerve. This mechanism is vital for PSH patients as it helps to mitigate symptoms like rapid heart rate, high blood pressure, and excessive sweating, which are caused by uncontrolled sympathetic hyperactivity. By enhancing parasympathetic activity, these treatments can reduce secondary brain injury, prevent weight loss from increased metabolic demand, and alleviate patient suffering.
The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-Temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia: Study Protocol for a Prospective, Open-Label, Parall.Influence of a specific, biorhythmically defined physical stimulus on deficient vasomotion in small-caliber arterioles in the subcutis in patients with diabetic polyneuropathy.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
625 Previous Clinical Trials
1,178,304 Total Patients Enrolled
Advancing a Healthier Wisconsin Endowment (AHW)UNKNOWN
Children's WisconsinUNKNOWN
1 Previous Clinical Trials
261 Total Patients Enrolled
~7 spots leftby Oct 2025