[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07264920":3,"trial-entities:NCT07264920":110,"trial-summary:NCT07264920":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":14,"eligibility_criteria":65,"std_ages":78,"locations":81,"central_contacts":103,"overall_officials":106,"references":108,"see_also_links":109},"NCT07264920","IRB00520236","Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain","NOT_YET_RECRUITING","2030-01","2026-08","2026-08-10","2026-10","Johns Hopkins University","OTHER",false,"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.","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.",[18,19],"Neuropathic Pain","Chronic Pain",[21,22,23],"pediatric oncology","chronic pain","neuropathic pain","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},70,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37],"Treatment - Scrambler Therapy MC-5A Device",[39],{"measure":40,"description":41,"timeFrame":42},"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",[44,48,52,56,58],{"measure":45,"description":46,"timeFrame":47},"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",{"measure":49,"description":50,"timeFrame":51},"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",{"measure":53,"description":54,"timeFrame":55},"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.",{"measure":57,"description":54,"timeFrame":55},"Change in total dose reduction for neuropathic pain",{"measure":59,"description":60,"timeFrame":61},"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","ALL","5 Years","26 Years",{"inclusion":66,"exclusion":69,"raw_text":77},[67,68],"Able to verbalize pain scores","Oncology patients with acute and\u002For chronic pain",[70,71,72,73,74,75,76],"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","Inclusion Criteria:\n\n* Able to verbalize pain scores\n* Oncology patients with acute and\u002For 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",[79,80],"CHILD","ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":100},"Johns Hopkins Children's Center","Baltimore","Maryland","21287","United States",[89,94,98],{"name":90,"role":91,"phone":92,"email":93},"Joann Hunsberger, MD","CONTACT","410-955-2448","jhunsbe1@jhmi.edu",{"name":95,"role":91,"phone":96,"email":97},"Colleen Mennie, RN, BSN","410-955-6412","cmennie1@jh.edu",{"name":90,"role":99},"PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},39.29038,-76.61219,[104,105],{"name":90,"role":91,"phone":92,"email":93},{"name":95,"role":91,"phone":96,"email":97},[107],{"name":90,"affiliation":12,"role":99},[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[19,112,18],"Malignant Neoplasm",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study planning to enroll up to 70 participants. It will evaluate the Scrambler Therapy MC-5A Device.","completed","Pediatric Electrocutaneous Analgesia for Neuropathic Pain","This study is testing a non-invasive treatment called Scrambler Therapy MC-5A Device for children and young adults (ages 5-26) who have neuropathic pain (nerve pain) due to cancer. The therapy uses electrodes placed on the skin to send low-level electrical signals that aim to \"scramble\" pain messages. The main goal is to see if this therapy can reduce your pain intensity, as measured by pain scales, and potentially decrease your need for pain medications. The study is looking to enroll up to 70 participants. The current status of the study is unclear.","Participants will be followed up at 1, 3, and 6 months after the last therapy session to evaluate long-term pain relief and changes in medication use.",92,"You would undergo 5 to 10 therapy sessions over 1-2 weeks, with pain assessed before and after each session. You would also complete additional questionnaires and have follow-up assessments at 1, 3, and 6 months.","Not stated in the trial record.",[34],"v2"]