Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
NCT Number: NCT06468189
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Migraine
Interventions: DEVICE: transcranial direct stimulation|DEVICE: Sham treatment
Sponsor: Istanbul Medipol University Hospital
Collaborators: Alanya Alaaddin Keykubat University|Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-11
Locations: İstanbul Medipol University, Istanbul, Beykoz, 33333, Turkey

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.

Primary Outcome Measures: Change in headache diary variables, The number of migraine attacks, pain intensity, duration of each attack and the number of painkillers taken will be evaluated. Patients will answer this diary throughout the entire experimental period (months)., Baseline (Before Treatment) / 1 month and 3 months after treatment
Secondary Outcome Measures: EEG Power Spectrum Analysis, 10 minutes of resting-state EEG recording.EEG data will be separated into one-second epochs after they are cleared of noise. Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform (FFT, Fast Fourier Transform) with 10% Hanning window, then power spectrum analysis will be performed, giving the frequency values for each electrode by averaging all FFTs. Maximum peaks will be determined in the delta (0.5-3.5 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (15-28 Hz) and gamma (28-48 Hz) frequency bands. these values will be used in statistical analysis for each person and electrode., Baseline (Before Treatment) / 1 month and 3 months after treatment|EEG Coherence Analysis, Coherence measurements at delta, theta, alpha, beta and gamma frequencies can be analyzed for either intra-hemispheric electrode connections or inter-hemispheric electrode connections.Coherence values take values between 0-1. Values close to 0 indicate that there is no connection at the determined frequency between the two calculated electrode regions, while values close to 1 indicate a high coupling between the two electrode regions.Coherence values will be calculated with the Brain Vision Analyzer program using the formula below.The data obtained during memory and visualization will be separated into one-second epochs after they are cleared of noise.Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform with 10% Hanning window.Then, these data will be calculated for all possible electrode pairs using the brain vision analysis program with the formula given below., Baseline (Before Treatment) / 1 month and 3 months after treatment|EEG functional connectivity analysis, 10 minutes of resting-state EEG recording. eLORETA software will be used for functional connectivity analysis. sLORETA /eLORETA is an online free software developed by Roberto Pascual-Marqui and his team (http://www.uzh.ch/keyinst/loreta.htm). eLORETA is an algorithm developed to solve the inverse problem and it does not contain localization bias even in the presence of noise . In this software, resting state data with eyes closed, separated into 2 second epochs, whose artifacts are cleaned by preprocessing, will be used. The relevant areas to be analyzed in the cortical plane and the relevant frequency band gaps will be determined. The time series containing the eLORETA current source density obtained from these areas will be calculated and a "lagged linear coherence" matrix will be created to be applied in graph theory (Vecchio et al., 2014). "Lagged linear coherence" will give correct physiological connectivity unaffected by volume conduction and low spatial resolution., Baseline (Before Treatment) / 1 month and 3 months after treatment|Changes in the Headache Impact Scale (HIT-6), Headache Impact Scale items evaluate vitality, pain, and psychological distress, as well as domains such as sociability, role, and cognitive functioning. Headache Impact Test (HIT-6) questionnaire was designed to helping describe and communicate the way people feel and what they cannot do because of headaches. Interpreting Headache Impact Test scores is achieve through a simple summary of the six items in the survey, ranging from 36 to 78 with larger scores reflecting greater impact. Levels of headache impact severity can be categorized using score ranges based on the HIT-6 interpretation guide into one of four areas: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78)., Baseline (Before Treatment) / 1 month and 3 months after treatment|Changes in Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10)., Baseline (Before Treatment) / 1 month and 3 months after treatment|MoCA Tests Scores, The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal., Baseline (Before Treatment) / 1 month and 3 months after treatment|Beck depression Tests Scores, The Beck Depression Inventory (BDI; Beck \& Steer, 1993) is a 21-item self-report instrument that generates one score reflecting the level of depression as being minimal, mild, moderate, or severe., Baseline (Before Treatment) / 1 month and 3 months after treatment|Anxiety scales, Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe., Baseline (Before Treatment) / 1 month and 3 months after treatment|tDCS side effect registration form, Any side effects occurring in the application area (during or after) Any general side effects that occur at the end of the application will be recorded., Baseline (Before Treatment) / 1 month and 3 months after treatment