Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

NCT07264920 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00520236
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuropathic Pain; Chronic Pain

Keywords

pediatric oncology; chronic pain; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.

  immediately prior to and immediately following each session

• Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions.

  Prior to first therapy session and immediately after final therapy session

• Change in number of medications used, daily morphine equivalents for opioids

  Prior to first therapy session up to 1 week following last therapy session.

• Change in total dose reduction for neuropathic pain

  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.

  1 month post therapy sessions, 6 months post therapy sessions

Study Arms (1)

Treatment - Scrambler Therapy MC-5A Device

EXPERIMENTAL

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

Interventions

Scrambler Therapy MC-5A Device 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.

Treatment - Scrambler Therapy MC-5A Device

Eligibility Criteria

• Age: 5 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joann Hunsberger, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joann Hunsberger, MD

CONTACT

410-955-2448; jhunsbe1@jhmi.edu

Colleen Mennie, RN, BSN

CONTACT

410-955-6412; cmennie1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)