Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01816958
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2013-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuromodulation to Facilitate the Effect of Ketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-20', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Assessment of Function in DSM-4R', 'timeFrame': 'up to 3 years', 'description': 'treat in order to cause remission of disability'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thalamocortical dysrhythmia', 'transcranial magnetic stimulation (TMS)', 'transcranial Electrical Stimulation (tES)', '(N-methyl-D-aspartate) NMDA-R antagonist', 'ketamine infusion', 'neuromodulation', 'synergistic effect', 'remission'], 'conditions': ['Depression', 'Chronic Pain', 'Substance Abuse']}, 'descriptionModule': {'briefSummary': 'application of external neuromodulation along with ketamine infusion.', 'detailedDescription': 'apply TMS concurrent with ketamine infusion in order to increase the likliehood \\& strength of therapeutic benefit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients within my own clinic, suffering with chronic emotional and/or somatic pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronically ill,\n* treatment-resistant\n\nExclusion Criteria:\n\n* active psychosis'}, 'identificationModule': {'nctId': 'NCT01816958', 'acronym': 'TMS/ketamine', 'briefTitle': 'Neuromodulation to Facilitate the Effect of Ketamine', 'organization': {'class': 'OTHER', 'fullName': 'The Neuroscience Center, LLC'}, 'officialTitle': 'Treatment of Thalamocortical Dysrhythmia Using External Neuromodulation to Facilitate the Therapeutic Effect of Ketamine.', 'orgStudyIdInfo': {'id': '12_1293'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic depression and/or pain', 'description': 'co-administration of TMS and infused ketamine for patients with chronic pain of psyche and/or soma', 'interventionNames': ['Other: co-administration of TMS and infused ketamine']}], 'interventions': [{'name': 'co-administration of TMS and infused ketamine', 'type': 'OTHER', 'description': 'co-administration of TMS and infused ketamine', 'armGroupLabels': ['chronic depression and/or pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60015', 'city': 'Deerfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Neuroscience Center', 'geoPoint': {'lat': 42.17114, 'lon': -87.84451}}], 'overallOfficials': [{'name': 'Steven R Devore Best, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Neuroscience Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Neuroscience Center, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}