Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04833920
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2021-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-03', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-03', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the visual analogue scale', 'timeFrame': '0 (prestimulation), on the 5th day, 15th days and one month after the last session', 'description': 'patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable'}], 'secondaryOutcomes': [{'measure': 'changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)', 'timeFrame': '0 (prestimulation),on the 5th day, 15th days and one month after the last session', 'description': 'the patients will be asked to describe his pain by answering questions in yes or no; score ≥ 12 suggests neuropathic pain is likely to be involved and score \\< 12 suggests that neuropathic pain is unlikely to be involved'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain stimulation', 'chemotherapy induced peripheral neuropathy'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)', 'detailedDescription': 'Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment\n\nExclusion Criteria:\n\n* patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia,\n* higher brain dysfunction,\n* migraine headache,\n* brain cancer or metastasis and\n* those known to have epilepsy'}, 'identificationModule': {'nctId': 'NCT04833920', 'briefTitle': 'Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': '539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active tDCS', 'description': 'tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days', 'interventionNames': ['Device: transcranial dirrect current brain stimuation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tDCS', 'description': 'tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds', 'interventionNames': ['Device: transcranial dirrect current brain stimuation']}], 'interventions': [{'name': 'transcranial dirrect current brain stimuation', 'type': 'DEVICE', 'description': 'tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day),', 'armGroupLabels': ['active tDCS', 'sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11715', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shereen M Kamal, Lecturer', 'role': 'CONTACT', 'email': 'sheridouh79@yahoo.com', 'phone': '01006279209'}], 'facility': 'South Egypt Cancer Institute', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Shereen M Kamal, Associate professor', 'role': 'CONTACT', 'email': 'sheridouh79@yahoo.com', 'phone': '01006279209'}], 'overallOfficials': [{'name': 'Shereen M Kamal, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Shereen Mamdouh', 'investigatorAffiliation': 'Assiut University'}}}}