Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT07061769
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-11
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in Neuropathic Pain Intensity', 'timeFrame': '12 weeks', 'description': 'Measured through scores in the Neuropathy Pain Scale. The Neuropathy Pain Scale uses a range a 0 to 10, with 0 being no pain/sensation and 10 being the most intense pain/sensation imaginable.'}, {'measure': 'Decrease in Numeric Pain Rating.', 'timeFrame': '12 weeks', 'description': 'Measured through Numeric Pain Rating surveys. The numeric pain rating scale uses a range of 0 to 10, with 0 being no pain and 10 being the worst pain possible.'}, {'measure': 'Improvement in Neuropathic Pain Symptoms', 'timeFrame': '12 weeks', 'description': 'Measured in weekly scores in the Neuropathic Pain Symptom Inventory. The inventory uses a scale of 1 to 10, with 1 being the no symptom and 10 being the worst symptom imaginable.'}], 'secondaryOutcomes': [{'measure': 'Decrease of pain-related interference', 'timeFrame': '12 weeks', 'description': 'Examine if SHIFT results in a decrease of pain related interferences on a weekly basis. The PEG scale assesses how much pain interferes with weekly abilities on a scale of 0 to 10, with 0 being no interference/pain and ten being complete interference/worst pain imaginable.'}, {'measure': 'Decrease of pain-related stress', 'timeFrame': '12 weeks', 'description': 'Examine if SHIFT results in a decrease of perceived stress related to pain on a weekly basis, using the perceived stress scale. The PSS examines how well patients have been able to sleep on a scale of 0 to 4 (0 being never and 4 being very often).'}, {'measure': 'Decrease of pain-related anxiety', 'timeFrame': '12 weeks', 'description': 'Examine if SHIFT results in a decrease of anxiety related to pain as measured by the GAD-7. The GAD 7 uses a scale of 0 (not at all) to 3 (nearly every day) to measure how often a patient feels anxiety.'}, {'measure': 'Decrease of pain-related inflammatory markers', 'timeFrame': '12 weeks', 'description': 'Examine if SHIFT results in a decrease of inflammatory markers in the blood, specifically a decrease in the presence of IL-6.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chemotherapy Induced Peripheral Neuropathy', 'Chemotherapy Induced Peripheral Neuropathy (CIPN)', 'Chemotherapy Induced Pain Neuropathy', 'Chemotherapy Induced Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine a low-intensity, low-risk cranial PEMF device and its effectiveness with helping cancer patients manage neuropathy symptoms from chemotherapy. Eligible patients are individuals who have been diagnosed with chemotherapy-induced peripheral neuropathy or are experiencing pain due to chemotherapy and are eighteen to sixty. The main questions the study aims to answer are:\n\nTo examine whether the application of low intensity, low frequency PEMF (by the System for Heterogeneous Integrated magnetic Field Transmission (SHIFT)) results in a significant decrease in neuropathic pain intensity.\n\nTo examine if SHIFT results in a decrease of pain related interference and associated symptoms of CIPN.\n\nResearchers will compare an active, treatment arm to a placebo, SHAM arm. Participants will be required to use the device once daily, fill out daily, weekly, and monthly surveys. They will have to do one blood draw at the beginning of the study and one at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to use smart phone and willing to receive text messages/emails\n* Has CIPN disorder/neuropathic pain related to chemotherapy\n* Able and willing to follow instructions\n* Not participated in any other clinical study within the past two months that may influence the results of this study\n\nExclusion Criteria:\n\n* History of seizures\n* Hydrocephalic\n* Had a change in medical therapy related to the treatment of neuropathy or chronic pain in the last fourteen days\n* Received repetitive transcranial magnetic stimulation (rTMS) in the last 60 days\n* Implanted device or metal in the brain\n* History of brain bleed in the last six months\n* History of suicidal behavior, bipolar disorder, schizophrenia\n* Active radiation over the scalp\n* Brain metastases\n* Currently participates in other neuropathic pain studies\n* Has any other medical condition that would prevent them from participating, including scalp wounds, hyperhidrosis, sensitive scalp, rash\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT07061769', 'briefTitle': 'Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'FluxWear, INC'}, 'officialTitle': 'Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms', 'orgStudyIdInfo': {'id': '1391997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Device', 'interventionNames': ['Device: SHIFT']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Device', 'interventionNames': ['Device: SHIFT']}], 'interventions': [{'name': 'SHIFT', 'type': 'DEVICE', 'description': 'SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA.', 'armGroupLabels': ['Sham Device', 'Treatment Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Spine Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FluxWear, INC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hoag Memorial Hospital Presbyterian', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}