Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 8:22 PM
Study NCT ID:
NCT07343427
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of GON PRF on Central Sensitization in Migraine Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single-group, prospective interventional study in which all enrolled participants undergo ultrasound-guided pulsed radiofrequency of the greater occipital nerve as part of routine clinical care. Clinical and patient-reported outcomes are assessed at baseline and at 1 and 3 months following the intervention to evaluate within-subject changes over time. No control or comparator group is included.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Central Sensitization Inventory (CSI) Total Score', 'timeFrame': 'Baseline to 3 months after greater occipital nerve pulsed radiofrequency', 'description': 'Change in central sensitization symptoms assessed using the Central Sensitization Inventory (CSI), a validated 25-item self-reported questionnaire with scores ranging from 0 to 100, where higher scores indicate greater symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Change in Allodynia Symptom Checklist (ASC-12) Score', 'timeFrame': 'Baseline to 1 month and 3 months after the procedure', 'description': 'The Allodynia Symptom Checklist-12 (ASC-12) is a patient-reported outcome measure assessing the presence and severity of cutaneous allodynia during migraine attacks. The total score ranges from 0 to 24, with higher scores indicating more severe allodynia symptoms. This outcome is defined as the change in ASC-12 total score from baseline to 1 month and 3 months of follow-up.'}, {'measure': 'Change in Migraine Disability Assessment Scale (MIDAS) Score', 'timeFrame': 'Baseline to 1 month and 3 months after the procedure', 'description': 'The Migraine Disability Assessment (MIDAS) questionnaire evaluates headache-related disability over the past 3 months by quantifying the impact of migraines on work, household, and social activities. The total MIDAS score ranges from 0 to 270, with higher scores indicating greater migraine-related disability. This outcome is defined as the change in MIDAS total score from baseline to 1 month and 3 months of follow-up.'}, {'measure': 'Change in Acute Migraine Medication Use', 'timeFrame': 'Baseline to 1 month and 3 months after the procedure', 'description': 'Change in the number of days per month requiring acute migraine medication.'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 3 months after the procedure', 'description': 'Frequency and type of procedure-related adverse events recorded throughout the follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Central sensitization', 'Greater occipital nerve', 'Pulsed radiofrequency'], 'conditions': ['Migraine', 'Central Sensitization']}, 'referencesModule': {'references': [{'pmid': '38915302', 'type': 'RESULT', 'citation': 'Oliveira K, Dhondt N, Englesakis M, Goel A, Hoydonckx Y. Pulsed Radiofrequency Neuromodulation of the Greater Occipital Nerve for the Treatment of Headache Disorders in Adults: A Systematic Review. Can J Pain. 2024 May 15;8(1):2355571. doi: 10.1080/24740527.2024.2355571. eCollection 2024.'}, {'pmid': '36101891', 'type': 'RESULT', 'citation': 'Suzuki K, Suzuki S, Shiina T, Kobayashi S, Hirata K. Central Sensitization in Migraine: A Narrative Review. J Pain Res. 2022 Sep 7;15:2673-2682. doi: 10.2147/JPR.S329280. eCollection 2022.'}, {'pmid': '38493795', 'type': 'RESULT', 'citation': 'GBD 2021 Nervous System Disorders Collaborators. Global, regional, and national burden of disorders affecting the nervous system, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024 Apr;23(4):344-381. doi: 10.1016/S1474-4422(24)00038-3. Epub 2024 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Background: Central sensitization and cutaneous allodynia are key mechanisms implicated in migraine chronification and disability. Pulsed radiofrequency (PRF) of the greater occipital nerve (GON) has emerged as a neuromodulatory intervention for refractory headache disorders; however, its effects on central sensitization remain insufficiently characterized.\n\nObjective: To prospectively evaluate changes in central sensitization, allodynia, and migraine-related disability following GON pulsed radiofrequency in patients with migraine.\n\nMethods: In this prospective observational study, adult patients with episodic or chronic migraine undergoing ultrasound-guided GON pulsed radiofrequency were evaluated at baseline and at 1 and 3 months post-procedure. Central sensitization was assessed using the Central Sensitization Inventory (CSI), cutaneous allodynia using the Allodynia Symptom Checklist (ASC-12), and migraine-related disability using the Migraine Disability Assessment Scale (MIDAS). Monthly headache days and acute medication use were also recorded.\n\nResults: Changes in CSI, ASC-12, MIDAS scores, headache frequency, and acute medication use over follow-up were analyzed using repeated-measures statistical methods.\n\nConclusions: This study provides prospective data on sensory and clinical outcomes following GON pulsed radiofrequency, contributing to the understanding of its potential role in modulating central sensitization in migraine.', 'detailedDescription': 'Migraine is a highly prevalent neurological disorder associated with substantial disability, reduced quality of life, and significant socioeconomic burden. Increasing evidence indicates that migraine chronification is closely linked to central sensitization, characterized by enhanced excitability of central nociceptive pathways, impaired pain modulation, and the clinical manifestation of cutaneous allodynia. Persistent central sensitization is considered a key mechanism underlying increased attack frequency, treatment refractoriness, and migraine-related disability.\n\nThe greater occipital nerve (GON), originating from the dorsal ramus of the C2 spinal nerve, provides sensory innervation to the occipital region and has direct anatomical and functional connections with the trigeminocervical complex. Modulation of afferent input from the GON has been shown to influence trigeminal nociceptive processing, supporting its role as a therapeutic target in migraine and other primary headache disorders. Although GON blocks may reduce headache burden, their effects are typically transient, highlighting the need for longer-lasting neuromodulatory strategies.\n\nPulsed radiofrequency (PRF) is a minimally destructive neuromodulation technique that delivers short bursts of high-voltage electrical current while maintaining tissue temperatures below neurodestructive thresholds. Unlike continuous radiofrequency ablation, PRF is believed to exert its effects through neuromodulatory mechanisms rather than structural nerve injury. Previous studies have suggested that GON-targeted PRF may reduce headache frequency and intensity; however, data regarding its effects on central sensitization and sensory amplification in migraine remain limited.\n\nThis prospective observational study is designed to evaluate changes in central sensitization, cutaneous allodynia, and migraine-related disability following ultrasound-guided GON pulsed radiofrequency in patients with episodic or chronic migraine. Adult patients meeting International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for migraine and scheduled for GON PRF as part of routine clinical care will be enrolled. All procedures will be performed under sterile operating room conditions using ultrasound guidance to identify the GON between the obliquus capitis inferior and semispinalis capitis muscles. PRF will be applied with standardized parameters, maintaining electrode tip temperature at or below 42°C.\n\nParticipants will undergo clinical assessments at baseline and at 1 and 3 months after the procedure. Central sensitization will be assessed using the Central Sensitization Inventory (CSI), cutaneous allodynia using the Allodynia Symptom Checklist (ASC-12), and migraine-related disability using the Migraine Disability Assessment Scale (MIDAS). In addition, monthly moderate and severe headache days and acute migraine medication use will be recorded. Adverse events related to the procedure will be systematically monitored throughout the follow-up period.\n\nBy prospectively evaluating sensory and clinical outcomes over time, this study aims to provide detailed observational data on the potential neuromodulatory effects of GON pulsed radiofrequency on central sensitization and migraine-related disability. The findings are expected to contribute to a better understanding of patient-reported sensory changes following GON PRF and to inform future controlled studies investigating neuromodulation-based interventions in migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n\nDiagnosis of episodic or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)\n\nPlanned to undergo ultrasound-guided greater occipital nerve pulsed radiofrequency as part of routine clinical care\n\nAbility to complete self-reported questionnaires (CSI, ASC-12, MIDAS)\n\nWillingness and ability to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of other primary headache disorders (e.g., cluster headache, tension-type headache as the primary diagnosis)\n\nSecondary headache disorders, including headache attributed to structural, infectious, inflammatory, or vascular causes\n\nPrior greater occipital nerve pulsed radiofrequency treatment within the past 12 months\n\nHistory of cervical spine surgery, significant cervical trauma, or structural pathology that may interfere with the procedure\n\nKnown coagulopathy or current use of anticoagulant therapy that cannot be safely interrupted\n\nLocal infection at or near the planned injection site\n\nSevere uncontrolled psychiatric or neurological disorders that may impair study participation or questionnaire reliability\n\nPregnancy or breastfeeding\n\nInability to comply with follow-up visits or study procedures'}, 'identificationModule': {'nctId': 'NCT07343427', 'acronym': 'GON PRF-CS', 'briefTitle': 'Impact of GON PRF on Central Sensitization in Migraine Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Central Sensitization and Migraine Disability Following Greater Occipital Nerve Pulsed Radiofrequency: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'TABED 2-25-979'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Greater Occipital Nerve Pulsed Radiofrequency', 'description': 'Participants assigned to this arm will undergo ultrasound-guided pulsed radiofrequency of the greater occipital nerve as part of routine clinical care. The procedure will be performed under sterile operating room conditions with standardized pulsed radiofrequency parameters, maintaining electrode tip temperature at or below 42°C. Clinical and patient-reported outcomes will be assessed at baseline and at 1 and 3 months following the intervention.', 'interventionNames': ['Procedure: Greater occipital nerve radiofrequency']}], 'interventions': [{'name': 'Greater occipital nerve radiofrequency', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided pulsed radiofrequency will be applied to the greater occipital nerve under sterile operating room conditions. Participants will be positioned prone with the neck in flexion. Using a linear ultrasound transducer, the greater occipital nerve will be identified in the fascial plane between the obliquus capitis inferior and semispinalis capitis muscles at the C2 level. A 22-gauge radiofrequency cannula with a 5-mm active tip will be advanced using an in-plane technique toward the target nerve. Correct positioning will be confirmed by sensory stimulation at low voltage. Pulsed radiofrequency will be delivered at 45 V for 360 seconds with a pulse frequency of 5 Hz and pulse width of 5 ms, while maintaining the electrode tip temperature at or below 42°C. Participants will be monitored during and after the procedure according to standard clinical practice.', 'armGroupLabels': ['Greater Occipital Nerve Pulsed Radiofrequency']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, pain specialist', 'investigatorFullName': 'Gülçin Babaoğlu', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}