What prior FDA approvals exist?

There are no specific FDA-approved treatments for Paroxysmal Sympathetic Hyperactivity (PSH) that directly match the mechanism of action of the Percutaneous Electrical Nerve Field Stimulation (PENFS) device. However, vagus nerve stimulation (VNS) has been approved for other conditions such as epilepsy and depression, which similarly involve modulation of the nervous system to achieve therapeutic effects. These treatments share a common goal of influencing parasympathetic activity to manage symptoms.

What other types of research exist?

Promising, novel alternatives to PENFS for treating Paroxysmal Sympathetic Hyperactivity (PSH) include: 1) Transcutaneous Vagus Nerve Stimulation (tVNS), which non-invasively stimulates the vagus nerve to increase parasympathetic activity. 2) Spinal Cord Stimulation (SCS), which has been used to manage chronic pain and may help modulate autonomic nervous system activity. 3) Biofeedback therapy, which trains patients to control physiological functions such as heart rate and muscle tension, potentially reducing sympathetic overactivity.

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Neurostimulation

Neurostimulation for Paroxysmal Sympathetic Hyperactivity

Q: What is the mechanism of action of this treatment?

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.

Q: What side effects are associated with this type of intervention?

The most common treatments for Paroxysmal Sympathetic Hyperactivity (PSH) include medications such as muscle relaxants, anti-anxiety drugs, gabapentin, and narcotics, which can have side effects like drowsiness, dizziness, and dependency. For non-drug treatments like the Percutaneous Electrical Nerve Field Stimulation (PENFS) device, which increases parasympathetic activity by stimulating the vagus nerve, side effects are generally mild and may include local irritation or discomfort at the application site. There is no mention of serious adverse events associated with PENFS in the context provided.

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-24hours, 25-48hours, 49-72hours, 73-96hours, 97-120hours

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met

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.