Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT04445766
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Complications of Microvascular Decompression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of pain relief 2 years after MVD', 'timeFrame': '2 years', 'description': 'Barrow Neurological Institute pain intensity score (BNI)'}, {'measure': 'Degree of complication rate 2 years after MVD', 'timeFrame': '2 years', 'description': 'The frequency of predefined major and minor complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurosurgery'], 'conditions': ['Trigeminal Neuralgia']}, 'referencesModule': {'references': [{'pmid': '36402970', 'type': 'DERIVED', 'citation': 'Andersen ASS, Heinskou TB, Rochat P, Springborg JB, Noory N, Smilkov EA, Bendtsen L, Maarbjerg S. Microvascular decompression in trigeminal neuralgia - a prospective study of 115 patients. J Headache Pain. 2022 Nov 19;23(1):145. doi: 10.1186/s10194-022-01520-x.'}]}, 'descriptionModule': {'briefSummary': 'The study is a non-interventional prospective observational study in patients with trigeminal neuralgia that undergoes micovascular decompression. The aim is to evaluate the efficacy and complications 2 years after microvascular decompression', 'detailedDescription': 'The aim of this study is to prospectively evaluate effect and complications 2 years after MVD using independent assessors of outcome and complications.\n\nData of outcome and complications is collected prospectively based on based on standardized follow-up schemes and questionnaires. Patients were assessed by independent assessors before surgery and 3, 6, 12 and 24 months after surgery. Current pain level was evaluated according to VAS and BNI pain scale. Complications were evaluated by the assessors by a questionnaire and physical examination. All patients undergo a pre-surgical protocolized 3.0 Tesla MRI of the brain and brainstem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We consecutively evaluated patients with the diagnosis of TN seen at the Danish Headache Center (DHC), a tertiary medical referral centre for headache and facial pain. Patients who were treated with MVD at the Department of Neurosurgery were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older.\n* Most give Signed informed Consent.\n* Must fullfil the ICHD-3 beta diagnostic criteria for classical TN.Patients with purely paroxysmal TN and patients with TN with concomitant persistent facial pain will be included.\n* If the ICHD-3 beta diagnostic criteria is fulfilled and if complete clinical history, neurological and physical examination and a 3.0 Tesla MRI do not raise any suspicion of another causative disease such as painful posttraumatic trigeminal neuropathy or symptomatic TN, subjects with sensory abnormalities detected at clinical neurological examination are also included.\n* Has had a 3.0 Tesla MRI according to the trigeminal neuralgia protocol, prior to the surgical intervention.\n* Semi-structured interview and neurological examination by the independent assessors prior to neurosurgical intervention.\n* Has tried at least one, preferably two, sodium channel blocker (either carbamazepine or oxcarbazepine) before referral to neurosurgery.\n\nExclusion Criteria:\n\nSubjects will be excluded if one of the following exclusion criteria is met:\n\n* Psychiatric or mental illness or condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.\n* Previous microvascular decompression as a treatment for trigeminal neuralgia'}, 'identificationModule': {'nctId': 'NCT04445766', 'briefTitle': 'Efficacy and Complications of Microvascular Decompression', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Efficacy and Complications of Microvascular Decompression - a Prospective Systematic Study of 115 Trigeminal Neuralgia Patients', 'orgStudyIdInfo': {'id': 'H-16019808'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Dr Med Sci', 'investigatorFullName': 'Lars Bendtsen', 'investigatorAffiliation': 'Danish Headache Center'}}}}