Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain (PEACE-NP)

This is a study evaluating the Scrambler Therapy device as a non-invasive treatment for neuropathic pain in pediatric oncology patients with metastatic bone disease. The primary goal is to assess changes in pain intensity and medication use, aiming to improve quality of life and reduce reliance on systemic pain medications.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Device: Scrambler Therapy MC-5A Device

Detailed Description

Eligible participants (ages 5-26) will undergo 5 to 10 therapy sessions over 1-2 weeks, with pain assessed before and after each session using age-appropriate scales. Additional assessments include the PainDETECT questionnaire and follow-ups at 1, 3, and 6 months to evaluate durability of pain relief and changes in medication use.

The study will enroll up to 70 participants over 5 years, with an expected evaluable sample size of 60. Statistical analyses will compare pre- and post-treatment pain scores, track pain trends across sessions, and assess long-term outcomes. Participants will continue receiving routine care, and therapy will be adjusted based on individual responses.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joann Hunsberger, MD; Phone Number: 410-955-2448; Email: jhunsbe1@jhmi.edu
• Study Contact Backup: Name: Colleen Mennie, RN, BSN; Phone Number: 410-955-6412; Email: cmennie1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Children's Center
      • Contact: Joann Hunsberger, MD; Phone Number: 410-955-2448; Email: jhunsbe1@jhmi.edu
      • Contact: Colleen Mennie, RN, BSN; Phone Number: 410-955-6412; Email: cmennie1@jh.edu
      • Principal Investigator: Joann Hunsberger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to verbalize pain scores
• Oncology patients with acute and/or chronic pain

Exclusion Criteria:

• Patients with Implantable Devices
• Epilepsy
• Pregnancy
• A history of myocardial infarction or ischemic heart disease within the past six months
• History of severe heart arrhythmia or equivalent heart disease
• Open Wounds or Infections at site of electrode placement
• A history of intolerance to transcutaneous electronic nerve stimulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment - Scrambler Therapy MC-5A Device; Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations.

Device: Scrambler Therapy MC-5A Device; Scrambler Therapy is a non-invasive electrocutaneous analgesia technique used to treat neuropathic pain. Each session lasts approximately 30-45 minutes and involves placing surface electrodes near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations. Pain intensity will be measured before and after each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale	The primary outcome is the change in self-reported pain intensity from baseline (prior to the first Scrambler Therapy session) to the post-final Scrambler Therapy session as measured by Numerical Rating Scale (NRS) or Wong-Baker Faces Pain Scale. The patients will rate pain using one of these scales at the beginning and the end of each treatment session with the primary comparison between the pre-first treatment session and the post-final treatment session. Total score range from 0-10, for both scales with a higher score indicating more pain.	Prior to first therapy session and immediately following last therapy session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.	Intra-session to session change in pain intensity across the full course of a single Scrambler Therapy session. Total score range from 0-10, with a higher score indicating more pain	immediately prior to and immediately following each session
Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions.	Total score range from 0-38. A higher score indicates a greater likelihood of neuropathic pain.	Prior to first therapy session and immediately after final therapy session
Change in number of medications used, daily morphine equivalents for opioids	This will be obtained through medical records.	Prior to first therapy session up to 1 week following last therapy session.
Change in total dose reduction for neuropathic pain	This will be obtained through medical records.	Prior to first therapy session up to 1 week following last therapy session.
Durability of pain relief as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.	Total score range from 0-10, with a higher score indicating more pain	1 month post therapy sessions, 6 months post therapy sessions

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Joann Hunsberger, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; neuropathic pain; pediatric oncology
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neuralgia
• Other Study ID Numbers: IRB00520236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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