← Back to Search

Neurostimulation

Neurostimulation for Paroxysmal Sympathetic Hyperactivity

Q: Are any slots still available for participants in this experiment?

By consulting the information on clinicaltrials.gov, we can confirm that this medical trial is still actively recruiting patients. It was first published on September 22nd 2022 and has since been amended on the 26th of the same month.

Q: Is the age threshold for enrollment in this trial restricted to under 35 years?

In order to be included in this medical experiment, the minimum participant age is 2 years old and the maximum allowable age is 17.

Q: May I join this research trial?

This study is currently sourcing 20 volunteers between the ages 2 and 17 with paroxysmal sympathetic hyperactivity. The eligibility requirements are: Children afflicted by ASBI-induced PSH, a moderate severity score (greater than 6) on their PSH rating scale, and Glasgow Coma Scale lower than 15.

Q: What are the expected benefits of this research?

As the primary outcome of this trial, a cohort of 2-17 year olds with acute severe <a href="https://www.withpower.com/clinical-trials/brain-injury">brain injury</a> (ASBI) and paroxysmal sympathetic hyperactivity (PSH) will be monitored for up to 192 hours while using percutaneous electrical nerve field stimulation (PENFS). Secondary results include an assessment in maintenance and rescue medication use, heart rate variability's standard deviation of NN intervals (SDNN), as well as total power parameter. <a href="https://www.withpower.com/clinical-trials/all">All</a> data collected over 12 hour periods before and after PENFS therapy will then be compared against historical cohorts from January 2018 - August 2021 via spearman correlation coefficient analysis.

Q: How many participants are being included in this clinical investigation?

Affirmative. The clinical trial's data hosted on the website of clinicaltrials.gov attests to this study's current recruitment phase, which commenced on September 22nd 2022 and was updated lastly on September 26th 2022. A total of 20 individuals are to be enrolled from a single medical site for participation in the research experiment.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test whether a non-invasive device that sends electrical signals to the ear can help treat symptoms of Paroxysmal Sympathetic Hyperactivity, which include a fast heart rate, high blood pressure, and rapid breathing.

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.Check my eligibility

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.See study design

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

Select...

My pain severity is more than moderate.

Select...

My child is between 2-17 years old and has PSH due to ASBI.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,563 Total Patients Enrolled

Advancing a Healthier Wisconsin Endowment (AHW)UNKNOWN

Children's WisconsinUNKNOWN

1 Previous Clinical Trials

261 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots still available for participants in this experiment?

"By consulting the information on clinicaltrials.gov, we can confirm that this medical trial is still actively recruiting patients. It was first published on September 22nd 2022 and has since been amended on the 26th of the same month."

Answered by AI

Is the age threshold for enrollment in this trial restricted to under 35 years?

"In order to be included in this medical experiment, the minimum participant age is 2 years old and the maximum allowable age is 17."

Answered by AI

May I join this research trial?

"This study is currently sourcing 20 volunteers between the ages 2 and 17 with paroxysmal sympathetic hyperactivity. The eligibility requirements are: Children afflicted by ASBI-induced PSH, a moderate severity score (greater than 6) on their PSH rating scale, and Glasgow Coma Scale lower than 15."

Answered by AI

What are the expected benefits of this research?

"As the primary outcome of this trial, a cohort of 2-17 year olds with acute severe brain injury (ASBI) and paroxysmal sympathetic hyperactivity (PSH) will be monitored for up to 192 hours while using percutaneous electrical nerve field stimulation (PENFS). Secondary results include an assessment in maintenance and rescue medication use, heart rate variability's standard deviation of NN intervals (SDNN), as well as total power parameter. All data collected over 12 hour periods before and after PENFS therapy will then be compared against historical cohorts from January 2018 - August 2021 via spearman correlation coefficient analysis."

Answered by AI

How many participants are being included in this clinical investigation?

"Affirmative. The clinical trial's data hosted on the website of clinicaltrials.gov attests to this study's current recruitment phase, which commenced on September 22nd 2022 and was updated lastly on September 26th 2022. A total of 20 individuals are to be enrolled from a single medical site for participation in the research experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children

Binod Balakrishnan 2022. "Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05343988.