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Neurostimulation for Opiate Withdrawal in the PICU (NOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03975192
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : October 30, 2019
Information provided by (Responsible Party):
Karen Marcdante, Medical College of Wisconsin

Brief Summary:
This is a prospective pilot study to investigate the effects of Percutaneous Electrical Nerve Field Stimulation (PENFS) on symptoms of opioid withdrawal in pediatric patients in the intensive care unit.

Condition or disease Intervention/treatment Phase
Opiate Withdrawal Syndrome Device: Percutaneous Electrical Nerve Field Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study subject will be randomized to receive study treatment (PENFS device treatment) or the Standard of Care treatment (Methadone wean) for prevention of opiate withdrawal symptoms
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Neurostimulation on Opiate Withdrawal Symptoms in Pediatric ICU Patients
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Intervention Group
50% of subjects will be randomized to the Intervention group and will receive percutaneous electric nerve field stimulation (PENFS) through the BRIDGE Device for 120 hours to treat withdrawal symptoms in patients following opiate exposure in the PICU.
Device: Percutaneous Electrical Nerve Field Stimulation
Placement of the PENFS device immediately following the last scheduled opiate dose in the PICU with active stimulation for 120 hours.
Other Name: BRIDGE Device

No Intervention: Standard of Care Group
50% of subjects will be randomized to the Standard of Care group and will receive be started on the standardized PICU Methadone wean for patients following opiate exposure in the PICU.

Primary Outcome Measures :
  1. Withdrawal Assessment Tool (WAT-1) Score [ Time Frame: Study Day 0 through Study Day 5 ]
    Measurement of opiate withdrawal symptoms experienced by study subjects

Secondary Outcome Measures :
  1. Pain Medication Use [ Time Frame: Study Day 0 through Study Day 5 ]
    Total dose of pain medications used on each study day

  2. Pain Scores [ Time Frame: Study Day 0 through Study Day 5 ]
    Age appropriate pain score values for each study day

  3. Length of Stay [ Time Frame: PICU Admission ]
    Time PICU Admission to medical PICU discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 5 to 17 years
  • Admission to PICU at Children's Hospital of Wisconsin (CHW)
  • Exposure to at least 120 hours of continuous IV opioid administration.

Exclusion Criteria:

  • Age children <5 years
  • Known central nervous system injury (hypoxic ischemic injury, traumatic brain injury, postoperative craniotomies),
  • Plan to wean benzodiazepine dosing during the active study period
  • Patients who are developmentally delayed

    o Defined as inappropriately non-verbal for age and determined through review of the medical record and discussion with the PICU attending and consulting team members.

  • Known pregnancy

    o Any pregnancy testing done during the subject's hospitalization will be reviewed. This will only be monitored if required as SOC, but will not be collected for the purpose of the study alone.

  • Known seizure disorder
  • Known diagnosis of psoriasis or significant dermatological disease involving ear (?)
  • Patients with implantable devices (cardiac pacemaker, vagal nerve stimulator, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03975192

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Contact: Karen Marcdante, MD 414-266-3367
Contact: Kate Woods, MS 414-266-5936

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United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Karen Marcdante, MD    414-266-3360   
Contact: Kate Woods, MS    414-266-5936   
Sponsors and Collaborators
Medical College of Wisconsin
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Responsible Party: Karen Marcdante, Principal Investigator, Medical College of Wisconsin Identifier: NCT03975192    
Other Study ID Numbers: 1185104
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Karen Marcdante, Medical College of Wisconsin:
Opiate Withdrawal
Percutaneous Electric Nerve Field Stimulation
Pediatric Intensive Care Unit
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders