Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-06-26 @ 5:32 AM
Study NCT ID:
NCT03700502
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Magnetic Resonance Imaging of Brain Activity in Patients With Painful Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-07', 'studyFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2018-10-07', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resting-state functional Magnetic Resonance Imaging', 'timeFrame': 'one or two years', 'description': 'collect and analyze the data of brain fMRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resting state functional MRI', 'painful diabetic neuropathy'], 'conditions': ['Painful Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '33791018', 'type': 'DERIVED', 'citation': 'Liu X, Xu X, Mao C, Zhang P, Zhang Q, Jiang L, Yang Y, Ma J, Ye L, Lee KO, Wu J, Yao Z. Increased thalamo-cortical functional connectivity in patients with diabetic painful neuropathy: A resting-state functional MRI study. Exp Ther Med. 2021 May;21(5):509. doi: 10.3892/etm.2021.9940. Epub 2021 Mar 19.'}, {'pmid': '30506341', 'type': 'DERIVED', 'citation': 'Zhang Q, Zhang P, Yan R, Xu X, Mao C, Liu X, Li F, Ma J, Ye L, Yao Z, Wu J. A Single-Blinded Trial Using Resting-State Functional Magnetic Resonance Imaging of Brain Activity in Patients with Type 2 Diabetes and Painful Neuropathy. Diabetes Ther. 2019 Feb;10(1):135-147. doi: 10.1007/s13300-018-0534-x. Epub 2018 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'Patients with painful diabetic neuropathy (PDN) often combine with anxiety and depression. However, the pathogenesis of PDN is unclear, especially the mechanism associated with central nervous system. The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism.The investigators evaluated the symptoms, signs and mental conditions of patients with PDN and non-pain neuropathy. The brain Blood Oxygen Level Dependent (BOLD) fMRI scan was performed in patients together with some gender and age matched healthy controls. Maybe this study can find that patients with PDN have abnormal brain activity, indicating central nervous system may contribute to painful diabetic neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Meet the diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Voluntary participation and signing informed consent\n* 18 to 60 years old with junior high school education or above\n* meeting the 1999 WHO type 2 diabetes diagnostic criteria: having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/L; (2) fasting blood glucose more than 7 mmol/L; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/L\n* The diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain\n\nExclusion Criteria:\n\n* left-hand writers\n* neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, Green Barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency\n* patients with severe cerebral vascular disease\n* diagnosed mental disorders such as depression, anxiety and Alzheimer's disease\n* patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias"}, 'identificationModule': {'nctId': 'NCT03700502', 'briefTitle': 'Functional Magnetic Resonance Imaging of Brain Activity in Patients With Painful Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Use Resting-state Functional Magnetic Resonance Imaging (Rs-fMRI) to Explore the Brain Activity in Patients With Painful Diabetic Neuropathy (PDN) in Order to Study Central Mechanism of PDN.', 'orgStudyIdInfo': {'id': '201605027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with painful diabetic neuropathy', 'interventionNames': ['Diagnostic Test: resting-state functional Magnetic Resonance Imaging']}, {'label': 'diabetics with non-pain neuropathy', 'interventionNames': ['Diagnostic Test: resting-state functional Magnetic Resonance Imaging']}, {'label': 'gender and age matched healthy controls', 'interventionNames': ['Diagnostic Test: resting-state functional Magnetic Resonance Imaging']}], 'interventions': [{'name': 'resting-state functional Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.', 'armGroupLabels': ['diabetics with non-pain neuropathy', 'gender and age matched healthy controls', 'patients with painful diabetic neuropathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Dan Wu, master', 'role': 'CONTACT', 'email': 'wujindandan@sina.com', 'phone': '0086-18951670336'}, {'name': 'Qing Zhang, master', 'role': 'CONTACT', 'email': 'zhangqingwork@sina.com', 'phone': '0086-15950522889'}], 'facility': 'the first hospital of Nanjing', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jin Dan Wu, master', 'role': 'CONTACT', 'email': 'wujindandan@sina.com', 'phone': '0086-18951670336'}, {'name': 'Qing Zhang, master', 'role': 'CONTACT', 'email': 'zhangqingwork@sina.com', 'phone': '0086-15950522889'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu Province Nanjing Brain Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}