Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-29 @ 11:55 PM
Study NCT ID:
NCT05451251
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrating the feasibility of the intervention by assessing protocol completion without deviation', 'timeFrame': '24 months', 'description': 'Protocol completion defined by:\n\n* Lead implantation with success\n* Adjustment of stimulation parameters to minimize adverse effects\n* Minimal follow-up of 6 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Lead implantation accuracy', 'timeFrame': '24 months', 'description': 'Difference between target and actual lead position'}, {'measure': 'Pain evolution', 'timeFrame': '24 months', 'description': 'Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.'}, {'measure': 'Facial numbness', 'timeFrame': '24 months', 'description': 'Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.'}, {'measure': 'Complications', 'timeFrame': '24 months', 'description': 'Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.'}, {'measure': 'Quality of life progression', 'timeFrame': '24 months', 'description': 'Assessed by the Brief Pain Inventory-Facial (BPI-Facial)'}, {'measure': 'Patient acceptability of the procedure', 'timeFrame': '24 months', 'description': 'Assessed by a Likert scale with a maximum score of 8. A low score on this scale indicates low acceptability of the surgical procedure, while a high score indicates high acceptability.'}, {'measure': 'Patient global impression of change', 'timeFrame': '24 months', 'description': 'Assessed by The Patient Global Impression of Change (PGIC) questionnaire with a maximum score of 18. A low score indicates a low impression of change while a high score indicates a high impression of change.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Deep brain stimulation', 'Pontine lesion'], 'conditions': ['Trigeminal Neuralgia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis.\n\nThese patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief.\n\nHoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults of at least 18 years old\n* Refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy).\n* Pontine lesion proved by MRI in contact with trigeminal nerve tract\n\nExclusion Criteria:\n\n* Absolute contraindication to MRI\n* Medical contraindication to the procedure'}, 'identificationModule': {'nctId': 'NCT05451251', 'briefTitle': 'Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study', 'orgStudyIdInfo': {'id': '2025-4672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep brain stimulation', 'description': 'Implantation of deep brain stimulation lead within the pontine lesion', 'interventionNames': ['Device: Deep brain stimulation']}], 'interventions': [{'name': 'Deep brain stimulation', 'type': 'DEVICE', 'description': 'Implantation of deep brain stimulation lead within the pontine lesion', 'armGroupLabels': ['Deep brain stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5H3', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mélodie Grondin-Lavigne, MD MSc candidate', 'role': 'CONTACT', 'email': 'melodie.grondin-lavigne@usherbrooke.ca', 'phone': '819-346-1110', 'phoneExt': '15130'}], 'facility': 'Centre Hospitalier Universitaire de Sherbrooke (CHUS)', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Christian Iorio-Morin, MD, PhD, FRCS(C)', 'role': 'CONTACT', 'email': 'Christian.Iorio-Morin@usherbrooke.ca', 'phone': '819-346-1110', 'phoneExt': '16365'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Open on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}