Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-20 @ 5:20 AM
Study NCT ID:
NCT05328661
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2022-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathophysiological Mechanisms of Trigeminal Neuralgia - Neurophysiological Assessment of the Blink-reflex
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001767', 'term': 'Blinking'}], 'ancestors': [{'id': 'D012018', 'term': 'Reflex'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency and amplitude of blink reflex on the pain side of classical trigeminal neuralgia patients.', 'timeFrame': '1 year', 'description': "We place the stimulator above the emergence of the supraorbital nerve, with the distal pole placed below. The subject could be in a sitting or supine position. He keeps his eyes opened and relaxed. The final intensity of stimulation is generally between 5to 10mA, but higher intensities sometime are required. We don't start from this intensity, but we increase it gradually from 2mA, in steps of 1-2mA. The time between consecutive stimuli must not be under 45 seconds, in order to avoid habituation. Before the stimuli is delivered, we look at the real-time activity box to be sure that the subject is relaxed. We aim to record at least 2-3 consecutive sweeps with a stable latency of the R1 and R2 components."}], 'secondaryOutcomes': [{'measure': 'Latency and amplitude of blink reflex on the pain side of idiopathic trigeminal neuralgia patients', 'timeFrame': '1 year', 'description': "We place the stimulator above the emergence of the supraorbital nerve, with the distal pole placed below. The subject could be in a sitting or supine position. He keeps his eyes opened and relaxed. The final intensity of stimulation is generally between 5to 10mA, but higher intensities sometime are required. We don't start from this intensity, but we increase it gradually from 2mA, in steps of 1-2mA. The time between consecutive stimuli must not be under 45 seconds, in order to avoid habituation. Before the stimuli is delivered, we look at the real-time activity box to be sure that the subject is relaxed. We aim to record at least 2-3 consecutive sweeps with a stable latency of the R1 and R2 components."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigeminal Neuralgia']}, 'referencesModule': {'references': [{'pmid': '37525973', 'type': 'DERIVED', 'citation': 'Bjerring B, Maarbjerg S, Heinskou T, Bendtsen L, Nikolic M, Grillo V, Icco R, Schytz HW. Comparison of the blink reflex in classical and idiopathic trigeminal neuralgia. Cephalalgia. 2023 Jul;43(7):3331024231191136. doi: 10.1177/03331024231191136.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to increase the understanding of the pathophysiology of trigeminal neuralgia by investigating the potential association between blink reflex abnormalities and phenotypical traits e.g. clinical characteristics and neuroimaging findings.', 'detailedDescription': 'We hypothesize:\n\nPatients with classical trigeminal neuralgia have a prolonged latency and reduced amplitudes of the blink-reflex on the pain side compared to patients with idiopathic TN\n\nThe latency and amplitudes of the blink-reflex is normal in patients with idiopathic trigeminal neuralgia\n\nPatients with concomitant persistent pain have a prolonged latency and reduced amplitudes of the blink reflex on the pain side compared to patients with pure paroxysmal TN\n\nMore men than women have a prolonged latency and reduced amplitudes of the blink reflex\n\nPatients with neurovascular contact with morphological changes have prolonged latency and reduced amplitudes of the blink reflex compared to patients with simple neurovascular contact\n\nPatients with secondary TN have prolonged latency and reduced amplitudes of the blink reflex compared to patients with simple neurovascular contact\n\nPatients with neurovascular contact with morphological changes have prolonged latency and reduced amplitudes of the blink reflex on the pain side compared to the non-pain side\n\nStudy population\n\nAll patients with the diagnosis of primary or secondary trigeminal neuralgia, seen in the outpatient clinic at the Danish Headache Center will be screened for eligibility to participate the study. Clinical routine is not influenced by participation in this observational study. Patients will be offered the same treatment as patients not participating.\n\nSetting\n\nAll patients with classic, idiopathic and symptomatic TN who have an appointment with a physician at the outpatient clinic at the Danish Headache Center as part of their work-up will, when they arrive at the center for their appointment, be asked if they want to participate in the study. The patients will be asked consecutively and there will be no prior recruitment of the patients. See recruitment below section 6.1. The study will not influence decisions regarding treatment of TN for the patients included in this protocol. Patients will be treated at the discretion of their own physician and the assessments listed below, are an integrated part of the clinical work-up and follow-up.\n\nAssessments\n\nStandardised data obtained from the medical chart\n\nThe following data will be obtained and registered from the medical chart of each patient that is included in the study:\n\nGender, date of birth, family history of TN or other facial pain\n\nDuration and localization of TN, use of and response to previous medical treatments\n\nSeverity of pain at the time of examination - using Verbal Numerical Rating Scale (VNRS)\n\nLocation and trigger factors for TN\n\nPrevious neurosurgical treatment for TN\n\nAdditional concomitant diseases and medication\n\nType and dosage of TN related medication, if any\n\nThe result of the neurological exam.\n\nShort interview on the examination day\n\nOn the day of the blink reflex examination, each patient will be asked by a trained biomedical laboratory scientist, nurse or medical student about the following:\n\nThen the number of paroxysms\n\nThe current level of pain (VNRS)\n\nThe current dosage of TN medicine, will be on the day of neurophysiological assessments.\n\nThe trained personnel will not ask about the side of pain and will not know the result of the MRI evaluation, so they are blinded in terms of side of pain and what type of TN patient they investigate.\n\nNeuroradiological assessment\n\nThe 3.0 Tesla MRI, performed according to a special TN protocol will be evaluated by a neuroradiologist, blinded for pain side. The neuro imaging data will be taken from the patient electronic journal. The following data will be registered:\n\nDegree (no contact, simple contact, displacement/compression or atrophy of the nerve), location and type (arterial, venous or mixed) of NVC\n\nNeurophysiological assessment (blink-reflex)\n\nElectromyographic Recording:\n\nWe want to record signals from both eyes (see image). Channel 1: left eye. Channel 2: right eye\n\nAfter connecting the cables to Channels 1 and 2 we can connect the electrodes to the black and red terminal wires: Black cable à active electrode: placed on the midline of the lower eyelid (orbicularis oculi muscles). Red cable à reference electrode: lateral to the eye (where the bone is superficial) We need one Green cable àground electrode: forehead or shoulder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Trigemnal neuralgia patients either with classic or idopathic TN', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of both sexes with trigeminal neuralgia must meet the following inclusion criteria to be eligible for participation:\n\nAge 18 years or older\n\nMust be able to give Signed Informed Consent prior to study entry. Appendix X\n\nMust fulfill the ICHD-3 diagnostic criteria1 for classical, idiopathic or secondary TN.\n\nHas had a 3.0 Tesla MRI according to the trigeminal neuralgia protocol, maximum 2 years before or after the assessment of the blink-reflex.\n\nHas had a semi-structured interview and neurological examination by the independent assessors, maximum 2 years before or after the assessment of the blink-reflex.\n\nExclusion Criteria:\n\n* Subjects will be excluded if one of the following exclusion criteria is met:\n\nIf the patient is not able to give informed consent due to mental challenges\n\nPrevious neurosurgical treatment (microvascular decompression and/or ablative procedures) for trigeminal neuralgia\n\nBilateral trigeminal neuralgia\n\nSymptomatic trigeminal neuralgia\n\nFindings of sensory abnormalities detected at clinical neurological examination'}, 'identificationModule': {'nctId': 'NCT05328661', 'acronym': 'TNBR', 'briefTitle': 'Pathophysiological Mechanisms of Trigeminal Neuralgia - Neurophysiological Assessment of the Blink-reflex', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Pathophysiological Mechanisms of Trigeminal Neuralgia - Neurophysiological Assessment of the Blink-reflex', 'orgStudyIdInfo': {'id': 'DanishHC180322Blink'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blink reflex', 'type': 'DIAGNOSTIC_TEST', 'description': 'The stimulator is directly connected to the right side of the frontal board. The sponge must be soaked in water or saline before being inserted into the stimulator. Dry them a bit to avoid leaking on the stimulator (it could create a bridge between the two poles). We want to stimulate the supraorbital nerve at its emergence from the eyebrow arch (the supraorbital foramen in the supra-orbital margin bone is easy to palpate 1 cm laterally to the root of the nose). We place the stimulator above the emergence of the supraorbital nerve, with the distal pole placed below. The final intensity of stimulation is generally between 5 to 10 mA, but higher intensities sometime are required.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Neurology', 'investigatorFullName': 'Henrik Schytz', 'investigatorAffiliation': 'Danish Headache Center'}}}}