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

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.

Conditions

• Migraine

Interventions

DEVICE

transcranial direct stimulation

Mars-01(Marslab, Turkey) transcranial direct current stimulation device works with a 9 volt battery and consists of two 5x5 (25 cm2) electrodes (anode and cathode). 3 consecutive sessions (days), cathodal to occipital cortex (O1 or O2, ipsilateral); Anodal application will be made to M1 (left). Active stimulation is 2mA tDCS with a 0 to 30 second acceleration period of 20 minutes per session. Placebo stimulation will be applied according to the device's own sham software protocol. Accordingly, the current consists of 30 seconds of increase from 0 to 2mA(milliamp), 10 seconds of stimulation, 30 seconds of decrease to 0 and 20 minutes of current-free application.

DEVICE

Sham treatment

The same device used for stimulation will be used, but no stimulation will be given.

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University

  collaborator OTHER

• Saglik Bilimleri Universitesi

  collaborator OTHER

• Istanbul Medipol University Hospital

  lead OTHER

Principal Investigators

• Lütfü Hanoğlu, Prof. DR. MD · Medipol University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2025-11-30

Completion

2025-11-30

Countries

• Turkey (Türkiye)

Study Locations