Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-28 @ 12:29 PM
Study NCT ID:
NCT02624661
Status:
TERMINATED
Last Update Posted:
2019-03-27
First Post:
2015-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}, {'id': 'D020773', 'term': 'Headache Disorders'}], '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': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005990', 'term': 'Glycerol'}], 'ancestors': [{'id': 'D000073999', 'term': 'Triose Sugar Alcohols'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'technical problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2015-11-26', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'For the follow-up period of 12 weeks', 'description': 'Number of adverse events and number of participants with adverse events after glycerol injection in the trigeminal ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.'}], 'secondaryOutcomes': [{'measure': 'Number of attacks with trigeminal neuralgia', 'timeFrame': '12 weeks'}, {'measure': 'Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale', 'timeFrame': '12 weeks', 'description': 'expressed as score on Visual analogue scale (VAS) for pain'}, {'measure': 'Intensity of the trigeminal neuralgia attacks assessed by questionnaire', 'timeFrame': '12 weeks', 'description': 'expressed by means of patient global impression of change questionnaire (PGIC)'}, {'measure': 'Number of doses of common analgesics', 'timeFrame': '12 weeks', 'description': 'week 1-4, week 5-8, week 9-12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigeminal ganglion', 'Glycerol', 'Nerve block'], 'conditions': ['Trigeminal Neuralgia', 'Headache Disorders']}, 'descriptionModule': {'briefSummary': 'Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed and written consent\n* Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria\n* Unsatisfactory effect of pharmacological treatment\n\nExclusion Criteria:\n\n* Microvascular decompression is seen as a better alternative\n* Heart or lung disease\n* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection\n* Psychiatric illness that hinders participation in the study\n* Known pregnancy or breast feeding\n* Inadequate use of contraceptives\n* Overuse or abuse of opioids\n* Abuse of medications, narcotics or alcohol\n* Anomalies which hinder or impede the used method of injection\n* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin'}, 'identificationModule': {'nctId': 'NCT02624661', 'briefTitle': 'Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique', 'orgStudyIdInfo': {'id': '2015/1192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glycerol injection', 'description': 'The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.', 'interventionNames': ['Drug: Glycerol']}], 'interventions': [{'name': 'Glycerol', 'type': 'DRUG', 'armGroupLabels': ['Glycerol injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Neuroscience, Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Erling A Tronvik, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}