Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-01 @ 12:06 PM
Study NCT ID:
NCT02594306
Status:
UNKNOWN
Last Update Posted:
2016-02-19
First Post:
2015-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}, {'id': 'D008839', 'term': 'Microelectrodes'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2015-10-14', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event related potentials(ERPs)', 'timeFrame': 'Day 3', 'description': 'Event related potentials include late positive potential（LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system.'}], 'secondaryOutcomes': [{'measure': 'local field potential(LFP)', 'timeFrame': 'in surgery,3 days after surgery', 'description': 'Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery.'}, {'measure': 'the 13-item obsessive compulsive drug use scale(OCDUS)', 'timeFrame': 'day 3'}, {'measure': 'Opiate Addiction Severity Inventory(OASI)', 'timeFrame': 'day 3'}, {'measure': "participants' craving for opioid drugs (VAS)", 'timeFrame': 'day 3', 'description': 'The 10-point visual analog scale(VAS)will be utilized at day 3.'}, {'measure': 'The Symptom Checklist-90(SCL-90)', 'timeFrame': 'day 3', 'description': 'The Symptom Checklist-90(SCL-90) is used to evaluate general status.'}, {'measure': 'Self-Rating Depression Scale(SDS)', 'timeFrame': 'day 3', 'description': 'Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.'}, {'measure': 'Yale-Brown Obsessive Compulsive Scale(Y-BOCS)', 'timeFrame': 'day 3', 'description': 'Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.'}, {'measure': 'The Eysenck Personality Questionnaire(EPQ)', 'timeFrame': 'day 3'}, {'measure': 'The Wechsler Memory Scale(WMS)', 'timeFrame': 'day 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drug addiction', 'Heroin', 'craving', 'event related potential', 'crystal methamphetamine'], 'conditions': ['Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': "Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.", 'detailedDescription': 'Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.\n\nAssessment for psychological craving degree of addiction patients is also a difficult thing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 65 years of age, male or female；\n2. Opiate addictive over 3 years；\n3. Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)；\n4. No obvious neuropsychiatry and personality disorders；\n5. No severe infectious disease；\n6. Good compliance and be able to complete follow up；\n7. General health is good，no severe liver、kidney、heart and lung disease；\n8. Informed consent issued\n\nExclusion Criteria:\n\n1. Severe cognitive disorders（MMSE scale: illiteracy≤17，primary school≤20，secondary school or above≤24）,bad compliance because of dementia,unable to issue the informed content；\n2. History of severe neuropsychiatric disease；\n3. Epilepsy；\n4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；\n5. Malignant tumor；History of brain trauma；Pregnant female；\n6. Patients are taking part in other clinical trials in recent 3 months；\n7. Being deem as unfit for the trials by researcher.'}, 'identificationModule': {'nctId': 'NCT02594306', 'briefTitle': 'Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation', 'orgStudyIdInfo': {'id': 'EEG/ERP and drug addiction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non operation', 'description': 'Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system.', 'interventionNames': ['Device: Emotional pictures stimulation system']}, {'type': 'EXPERIMENTAL', 'label': 'Deep brain stimulation', 'description': 'Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule', 'interventionNames': ['Device: Emotional pictures stimulation system', 'Procedure: Deep brain stimulation', 'Procedure: adjacent contact stimulation', 'Procedure: microelectrode']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Control', 'description': 'Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system.', 'interventionNames': ['Device: Emotional pictures stimulation system']}], 'interventions': [{'name': 'Emotional pictures stimulation system', 'type': 'DEVICE', 'description': 'Emotional pictures stimulation system is component of neutral and drug-related images.', 'armGroupLabels': ['Deep brain stimulation', 'Non operation', 'Standard Control']}, {'name': 'Deep brain stimulation', 'type': 'PROCEDURE', 'description': 'Deep brain stimulation of bilateral NAc/ALIC', 'armGroupLabels': ['Deep brain stimulation']}, {'name': 'adjacent contact stimulation', 'type': 'PROCEDURE', 'description': 'The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.', 'armGroupLabels': ['Deep brain stimulation']}, {'name': 'microelectrode', 'type': 'PROCEDURE', 'description': 'We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.', 'armGroupLabels': ['Deep brain stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-dong Gao, M.D.', 'role': 'CONTACT', 'email': 'gguodong@fmmu.edu.cn', 'phone': '+86 29 84777435'}, {'name': 'Xue-lian Wang, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of neurosurgery, Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Guo-dong Gao, M.D.', 'role': 'CONTACT', 'email': 'gguodong@fmmu.edu.cn', 'phone': '+86 29 84777435'}, {'name': 'Xue-lian Wang, M.D.', 'role': 'CONTACT', 'email': 'wxlian@fmmu.edu.cn', 'phone': '+86 29 84777284'}], 'overallOfficials': [{'name': 'Guo-dong Gao, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of neurosurgery, Tangdu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurosurgery Department', 'investigatorFullName': 'Guodong Gao', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}