Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-24 @ 9:09 AM
Study NCT ID:
NCT07264920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale', 'timeFrame': 'Prior to first therapy session and immediately following last therapy session', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.', 'timeFrame': 'immediately prior to and immediately following each session', 'description': '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'}, {'measure': 'Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions.', 'timeFrame': 'Prior to first therapy session and immediately after final therapy session', 'description': 'Total score range from 0-38. A higher score indicates a greater likelihood of neuropathic pain.'}, {'measure': 'Change in number of medications used, daily morphine equivalents for opioids', 'timeFrame': 'Prior to first therapy session up to 1 week following last therapy session.', 'description': 'This will be obtained through medical records.'}, {'measure': 'Change in total dose reduction for neuropathic pain', 'timeFrame': 'Prior to first therapy session up to 1 week following last therapy session.', 'description': 'This will be obtained through medical records.'}, {'measure': 'Durability of pain relief as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.', 'timeFrame': '1 month post therapy sessions, 6 months post therapy sessions', 'description': 'Total score range from 0-10, with a higher score indicating more pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pediatric oncology', 'chronic pain', 'neuropathic pain'], 'conditions': ['Neuropathic Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to verbalize pain scores\n* Oncology patients with acute and/or chronic pain\n\nExclusion Criteria:\n\n* Patients with Implantable Devices\n* Epilepsy\n* Pregnancy\n* A history of myocardial infarction or ischemic heart disease within the past six months\n* History of severe heart arrhythmia or equivalent heart disease\n* Open Wounds or Infections at site of electrode placement\n* A history of intolerance to transcutaneous electronic nerve stimulation'}, 'identificationModule': {'nctId': 'NCT07264920', 'acronym': 'PEACE-NP', 'briefTitle': 'Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain', 'orgStudyIdInfo': {'id': 'IRB00520236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment - Scrambler Therapy MC-5A Device', 'description': 'Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations.', 'interventionNames': ['Device: Scrambler Therapy MC-5A Device']}], 'interventions': [{'name': 'Scrambler Therapy MC-5A Device', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment - Scrambler Therapy MC-5A Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Joann Hunsberger, MD', 'role': 'CONTACT', 'email': 'jhunsbe1@jhmi.edu', 'phone': '410-955-2448'}, {'name': 'Colleen Mennie, RN, BSN', 'role': 'CONTACT', 'email': 'cmennie1@jh.edu', 'phone': '410-955-6412'}, {'name': 'Joann Hunsberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Johns Hopkins Children's Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Joann Hunsberger, MD', 'role': 'CONTACT', 'email': 'jhunsbe1@jhmi.edu', 'phone': '410-955-2448'}, {'name': 'Colleen Mennie, RN, BSN', 'role': 'CONTACT', 'email': 'cmennie1@jh.edu', 'phone': '410-955-6412'}], 'overallOfficials': [{'name': 'Joann Hunsberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}