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NCT05343988 · ClinicalTrials.gov registry record · NA
Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children
A NA study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05343988 is a NA study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 20 participants.
The verdict
NCT05343988, a NA study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Survivors of severe brain injury, such as lack of oxygen or severe traumatic brain injury, frequently experience Paroxysmal Sympathetic Hyperactivity (PSH). PSH is characterized by disabling symptoms such as a fast heart rate, high blood pressure, rapid breathing, rigidity, tremors, and sweating due to uncontrolled sympathetic hyperactivity in the nervous system. Effective treatment is necessary to decrease secondary brain injury, prevent weight loss from increased metabolic demand and reduce suffering. Currently, a combination of medications to slow down the sympathetic nervous system, muscle relaxants, anti-anxiety drugs, gabapentin, and narcotics are used to treat PSH. The sudden, recurrent attacks of PSH often require repeated rescue medications and multiple drugs with a high risk of side effects. Non-drug treatments for PSH may revolutionize treatment. The novel and non-invasive Percutaneous Electrical Nerve Field Stimulation (PENFS) device is an attractive and potentially effective treatment option for PSH. PENFS, applied to the external ear, has been shown to be effective for conditions such as abdominal pain, narcotic withdrawal, and cyclic vomiting syndrome, all which have similar symptoms to PSH. Therefore, the hypothesis is PENFS could be effective in the treatment of PSH. The electrical current delivered by the PENFS device is thought to increase parasympathetic activity by stimulating a branch of the vagus nerve. PENFS was shown to decrease central sympathetic nervous system activity by 36% within 5 minutes of being placed in the ear of a rat model. Similar central inhibition could improve symptoms of PSH. This pilot study aims to evaluate the feasibility of performing an efficacy trial of PENFS for children with PSH.
Interventions
- DEVICE Percutaneous Electrical Nerve Field Stimulation (PENFS) device application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-22 |
| Est. Completion | 2025-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05343988
The ClinicalTrials.gov registry entry for NCT05343988 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Percutaneous Electrical Nerve Field Stimulation (PENFS) device application is the first listed.
NCT05343988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05343988 about?
NCT05343988 is a clinical study titled "Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children". Survivors of severe brain injury, such as lack of oxygen or severe traumatic brain injury, frequently experience Paroxysmal Sympathetic Hyperactivity (PSH). PSH is characterized by disabling symptoms such as a fast heart rate, high blood pressure, rapid breathing, rigidity, tremors, and sweating due...
What is the current status of trial NCT05343988?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2022-09-22. Estimated completion is 2025-11-30.
What interventions are being tested in trial NCT05343988?
The interventions under investigation include: Percutaneous Electrical Nerve Field Stimulation (PENFS) device application (DEVICE).
Who is sponsoring clinical trial NCT05343988?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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