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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: Clinical Trial NA study, sponsored by Medical College of Wisconsin.
NCT05343988 is a NA study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients enrolled
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 |
Why NCT05343988 stopped before completion
NCT05343988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05343988's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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