Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-01-12 @ 12:28 PM
Study NCT ID:
NCT02465918
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclization of Motor Cortex Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain assessment with the McGill pain questionnaire to record impact of pain', 'timeFrame': 'At the end of each trial period, typically 14 days after change in stimulation setting'}], 'primaryOutcomes': [{'measure': 'Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings', 'timeFrame': 'At the End of each trial period, typically 14 days after change in stimulation settings'}], 'secondaryOutcomes': [{'measure': 'Quality of Life assessment with the SF-36 questionnaire', 'timeFrame': 'At the end of each trial period, typically at 14 days after change in stimulation settings'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '1705329', 'type': 'RESULT', 'citation': 'Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x.'}, {'pmid': '1792954', 'type': 'RESULT', 'citation': 'Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37.'}, {'pmid': '8657427', 'type': 'RESULT', 'citation': 'Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V.'}, {'pmid': '18541887', 'type': 'RESULT', 'citation': 'Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.'}]}, 'descriptionModule': {'briefSummary': 'Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest.\n\nThe strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control.\n\nThe aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient more than 18 years of age\n* Chronic neuropathic pain effectively treated with motor cortex stimulation\n* Stable medication during the trial\n* Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.\n\nExclusion Criteria:\n\n* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator\n* Technical malfunction of the MCS device\n* History of seizures\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02465918', 'briefTitle': 'Cyclization of Motor Cortex Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation', 'orgStudyIdInfo': {'id': 'H15-01420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Original Setting- MCS 30 min off/0 min off', 'description': 'Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour.', 'interventionNames': ['Device: motor cortex stimulation (Change of Stimulation Timing)']}, {'type': 'EXPERIMENTAL', 'label': 'MCS 25 min on/5 min off', 'description': 'Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour.', 'interventionNames': ['Device: motor cortex stimulation (Change of Stimulation Timing)']}, {'type': 'EXPERIMENTAL', 'label': 'MCS 20 min on/10 min off', 'description': 'Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour.', 'interventionNames': ['Device: motor cortex stimulation (Change of Stimulation Timing)']}, {'type': 'EXPERIMENTAL', 'label': 'MCS 15 min on/15 min off', 'description': 'Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour.', 'interventionNames': ['Device: motor cortex stimulation (Change of Stimulation Timing)']}], 'interventions': [{'name': 'motor cortex stimulation (Change of Stimulation Timing)', 'type': 'DEVICE', 'armGroupLabels': ['MCS 15 min on/15 min off', 'MCS 20 min on/10 min off', 'MCS 25 min on/5 min off', 'Original Setting- MCS 30 min off/0 min off']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'The Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor/Neurosurgeon', 'investigatorFullName': 'Christopher Honey', 'investigatorAffiliation': 'University of British Columbia'}}}}