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Active Not Recruiting NCT06468189

Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine

Conditions: Migraine

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Istanbul Medipol University Hospital

Location: İstanbul Medipol University Istanbul Beykoz

Summary

tDCS can be offered as an alternative to migraine patients who have frequent and severe attacks and who are resistant to or unresponsive to preventive drug therapy. Additionally, this technique may also be an option for patients who refuse or have contraindications to taking anti-migraine medications. A decrease in headache severity and frequency is expected with this neuromodulation applied to migraine patients with frequent attacks. Based on this hypothesis; This tested whether simultaneous modulation of motor (M1, left) and visual cortex (O1 or O2, ipsilateral) with tDCS applied for 3 consecutive days is an effective treatment for migraine patients for the following specific purposes . No significant undesirable effects are expected, except for possible side effects that are simple and do not require medical intervention, such as tingling or itching in the area where the electrodes are attached, moderate fatigue, mild headache, nausea at a rate of less than 3%, and insomnia at a rate of less than 1%. . The research will be conducted within the framework of ethical principles and in accordance with the good clinical practice protocol. A) The primary purpose of this study is to determine whether transcranial direct current stimulation applied simultaneously to the motor and visual cortex in migraine patients provides a significant reduction in pain due to migraine attacks compared to sham tDCS. Additionally, to evaluate the effects of this treatment, They will be measured changes in the number of migraine attacks, abortive medication intake (e.g., opioids, triptans), as well as overall improvement in cognitive status and quality of life. In addition, electrophysiological EEG evaluations, before and after treatment, and the results of these measurements, as a potential biomarker in migraine, will be compared in the active and sham groups. B) It is aimed to determine whether the clinical effects of tDCS are long-lasting. Therefore, It will compared whether there is a difference in improvement of migraine-related pain between active and sham tDCS at pre-treatment (baseline) assessments as well as at 1, 2, and 3 months after treatment. C) Finally, it will be examined whether tDCS treatment applied for 3 consecutive days in migraine patients is safe. Safety will be evaluated through neuropsychological testing and adverse event reporting.

Eligibility Criteria

Inclusion Criteria: * Episodic migraine without aura and with aura, with frequent attacks (\>4 or more), diagnosed according to the International Classification of Headache Disorders; The diagnosis must meet the 2018 ICHD-3 criteria for migraine without aura and migraine with aura. * Patients whose previous prophylactic treatments have failed and who cannot or do not want to use treatments for various reasons * The duration of the disease must be at least 12 months. * Not having received any botulinum toxin treatment in the last 3 months * Having the mental functionality and education to understand the scales used * Patients who volunteered to participate in the research. Exclusion Criteria: * Pregnancy or breastfeeding * People with clinical evidence of brain damage * Metallic implant head * Heart battery * History of seizures and chronic pain associated with other pathologies * Other major neurological or major neuropsychiatric diseases; * Other chronic pain syndromes; * Other types of primary or secondary headaches;

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06468189). StuddyBuddy aggregates publicly available trial information.