Neuropathic PainPEACE-NPNCT07264920
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
A study testing Scrambler Therapy MC-5A Device in people with Neuropathic Pain and Chronic Pain, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 26 years
- Conditions the study is for
- Neuropathic Pain, Chronic Pain
- What is being tested?
- Scrambler Therapy MC-5A Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Able to verbalize pain scores
- Oncology patients with acute and/or chronic pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Joann Hunsberger, MD, 410-955-2448, jhunsbe1@jhmi.edu
Colleen Mennie, RN, BSN, 410-955-6412, cmennie1@jh.edu
About this study
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.
Read the 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.
- Conditions
- Neuropathic Pain, Chronic Pain
- Being tested
- Scrambler Therapy MC-5A Device
- Keywords
- pediatric oncology, chronic pain, neuropathic pain
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler Therapy MC-5A DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Scrambler Therapy MC-5A Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 month post therapy sessions, 6 months post therapy sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joann Hunsberger, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264920
- Sponsor's protocol ID
- IRB00520236
- Acronym
- PEACE-NP
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07264920
- Acronym / sponsor ID
- PEACE-NP / IRB00520236
- Conditions
- Neuropathic Pain, Chronic Pain
- Keywords
- pediatric oncology, chronic pain, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - Scrambler Therapy MC-5A Device | Experimental | Device: Scrambler Therapy MC-5A DeviceSurface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations. |
Who may qualify
- Ages
- 5 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Able to verbalize pain scores
- Oncology patients with acute and/or chronic pain
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scrambler Therapy MC-5A DeviceScrambler 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. | Device | Treatment - Scrambler Therapy MC-5A Device |
Primary outcome
Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale
Time frame: Prior to first therapy session and immediately following last therapy session
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.
5 secondary outcomes
Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.
Time frame: immediately prior to and immediately following each session
Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions.
Time frame: Prior to first therapy session and immediately after final therapy session
Change in number of medications used, daily morphine equivalents for opioids
Time frame: Prior to first therapy session up to 1 week following last therapy session.
Change in total dose reduction for neuropathic pain
Time frame: 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.
Time frame: 1 month post therapy sessions, 6 months post therapy sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joann Hunsberger, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scrambler Therapy MC-5A Device in people with Neuropathic Pain and Chronic Pain, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joann Hunsberger, MD (410-955-2448, jhunsbe1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale (time frame: Prior to first therapy session and immediately following last therapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.