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

NCT06468189 | Active Not Recruiting

• 1 other identifier: 2023IMU_Migraine_tDCS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transcranial direct current stimulation; tDCS; migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• EEG Power Spectrum Analysis

  Baseline (Before Treatment) / 1 month and 3 months after treatment

• EEG Coherence Analysis

  Baseline (Before Treatment) / 1 month and 3 months after treatment

• EEG functional connectivity analysis

  Baseline (Before Treatment) / 1 month and 3 months after treatment

• Changes in the Headache Impact Scale (HIT-6)

  Baseline (Before Treatment) / 1 month and 3 months after treatment

• Changes in Visual Analogue Scale (VAS)

  Baseline (Before Treatment) / 1 month and 3 months after treatment

Study Arms (2)

tDCS

EXPERIMENTAL

tDCS Interictal application will be performed during the attack-free period. Experimental group, 3 consecutive sessions, cathodal to occipital cortex (O1 or O2, ipsilateral); anodal to M1 (left)

Device: transcranial direct stimulation

Sham

SHAM COMPARATOR

Control group, 3 consecutive sessions of sham stimulation to the same locations.

Device: Sham treatment

Interventions

transcranial direct stimulation DEVICE

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.

tDCS

Sham treatment DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Alanya Alaaddin Keykubat University: collaborator
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

İstanbul Medipol University

Istanbul, Beykoz, 33333, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Lütfü Hanoğlu, Prof. DR. MD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: June 21, 2024
• Study Start: March 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)