Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT06121232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009443', 'term': 'Neuritis'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'through study completion; an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathy;Peripheral']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if a process called neuromodulation can help to improve pain due to CIP', 'detailedDescription': 'Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds\n* Patients seen at Pain Management Center at MD Anderson Cancer Center\n* Patient ages greater or equal to 18 years but less than or equal to 85 years\n\nExclusion Criteria:\n\n* Patients with cognitive dysfunction\n* Patient with recent history (\\<6 months) of drug or alcohol abuse\n* Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection\n* Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds\n* Patients seen at Pain Management Center at MD Anderson Cancer Center\n* Patient ages greater or equal to 18 years but less than or equal to 85 years\n\nExclusion Criteria\n\n* Patients with cognitive dysfunction\n* Patient with recent history (\\<6 months) of drug or alcohol abuse\n* Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection\n* Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT06121232', 'briefTitle': "Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study", 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': "Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study", 'orgStudyIdInfo': {'id': '2023-0301'}, 'secondaryIdInfos': [{'id': 'NCI-2023-09269', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Group 1 will receive neuromodulation.', 'interventionNames': ['Device: Abbott® DRG / Abbott®/Medtronic® SCS']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Group 2 will not receive neuromodulation.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Abbott® DRG / Abbott®/Medtronic® SCS', 'type': 'DEVICE', 'description': 'Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Participants will not receive any intervention', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Saba Javed, M D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Anesthesia Education and Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}