Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03136302
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2017-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distance between stimulation electrode and motor fibers in mm', 'timeFrame': 'Intraoperative', 'description': 'Distances between the stimulation electrode and motor fibers as depicted on fiber tracking in millimeters in correlation to the threshold current for eliciting clinical side effects'}], 'secondaryOutcomes': [{'measure': 'Intraoperative intensity of stimulation in milliampere (mA)', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)'}, {'measure': 'Stimulation thresholds in milliampere (mA)', 'timeFrame': 'Intraoperative', 'description': 'Threshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects'}, {'measure': 'Change in disease score units on the UPDRS rating scale', 'timeFrame': 'twelve months', 'description': 'Assessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)'}, {'measure': 'Change in disease score units on the FTRS rating scale', 'timeFrame': 'twelve months', 'description': 'Assessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)'}, {'measure': 'Change in disease score units on the BFMDRS rating scale', 'timeFrame': 'twelve months', 'description': 'Assessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)'}, {'measure': 'Change in disease score units on the TWSTR rating scale', 'timeFrame': 'twelve months', 'description': 'Assessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)'}, {'measure': 'Change in disease score units on the PDQ-39 rating scale', 'timeFrame': 'twelve months', 'description': 'Assessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Improving Accuracy of Implanting Stimulation Electrodes']}, 'descriptionModule': {'briefSummary': 'The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.', 'detailedDescription': 'The main goal is to find out what are the optimal distances to these reference fiber tracts when stimulating and to find the optimal target. This has to be evaluated for each target, such as globus pallidus (Gpi), subthalamic nucleus (STN) and ventral intermediate nucleus of the thalamus (VIM) separately. This is of special importance as the investigators can demonstrate the internal capsule, which is often a generator of stimulation-induced side effects: tetanic muscle contractions, dysarthria and gaze deviations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who qualify for deep brain stimulation on the basis of a movement disorder and chronic pain', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient qualifying for deep brain stimulation on the basis of a movement disorder (Parkinson's Disease, tremor, dystonia) or chronic pain disease.\n* Informed consent\n\nExclusion Criteria:\n\n* Lack of consent\n* Electrical or other devices that preclude the performance of an MRI"}, 'identificationModule': {'nctId': 'NCT03136302', 'briefTitle': 'Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation', 'orgStudyIdInfo': {'id': 'DBS2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subthalamic Nucleus (STN)', 'description': "Patients with Parkinson's disease", 'interventionNames': ['Procedure: Deep Brain Stimulation']}, {'label': 'Globus Pallidus (Gpi)', 'description': 'Patients with Dystonia', 'interventionNames': ['Procedure: Deep Brain Stimulation']}, {'label': 'Ventral intermediate nucleus of the thalamus (VIM)', 'description': 'Patients with Tremor', 'interventionNames': ['Procedure: Deep Brain Stimulation']}], 'interventions': [{'name': 'Deep Brain Stimulation', 'type': 'PROCEDURE', 'description': 'Deep Brain Stimulation', 'armGroupLabels': ['Globus Pallidus (Gpi)', 'Subthalamic Nucleus (STN)', 'Ventral intermediate nucleus of the thalamus (VIM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lutz Weise, MD', 'role': 'CONTACT', 'email': 'lutz.weise@nshealth.ca', 'phone': '902-473-6850'}], 'facility': 'Queen Elizabeth Health Science Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Lutz Weise, MD', 'role': 'CONTACT', 'email': 'lutz.weise@nshealth.ca', 'phone': '902-473-6850'}], 'overallOfficials': [{'name': 'Lutz Weise, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}