Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease
Condition: Chronic Migraine, Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      The aim of the study was to investigate the effectiveness of non-invasive auricular vagus
      nerve stimulation on pain and pulse variability in women aged 18-55 years with migraine. It
      is also aimed to see the effects of vagus nerve stimulation from all directions by making
      pain, pulse, blood pressure and autonomic measurements.
    

Detailed description: 
      Migraine, a neurological disorder that causes severe disability, is characterized by
      recurrent moderate to severe attacks associated with vegetative symptoms. Patients with
      frequent attacks may overuse drugs, which can lead to migraine chronization and headache. In
      the last decade, neuromodulatory approaches have been developed for the treatment of
      headaches that do not respond adequately to treatment. Non-invasive neuromodulation
      techniques are an evolving field in migraine research and treatment. Non-invasive vagus nerve
      stimulation is one of the non-invasive neuromodulation techniques. Promising findings on
      vagus nerve stimulation in people with chronic pain, including migraine and cluster
      headaches, are slowly being recognized. Stimulation of the vagus nerve provides a way of
      regulating autonomic tone. Auricular vagus nerve stimulation regulates abnormal
      sympatho-vagal balance while activating the parasympathetic system, including
      anti-inflammatory pathways (cholinergic anti-inflammatory pathway and hypothalamic-pituitary
      adrenal axis). It is aimed to evaluate the effect on pain and pulse variability after vagus
      nerve stimulation in women with migraine disease and to learn how the vagus nerve crosses
      according to the pulse measurements taken from the right and left index fingers.
    

Intervention name(s): Auricular Vagus Nerve Stimulation
Intervention type(s): Device
Intervention description(s): First of all, the application will be explained to the participants and a signed consent form for the application will be obtained from the individuals. Groups; It will be in the form of Right Ear Stimulation, Left Ear Stimulation and Bilateral Ear Stimulation group. Non-invasive auricular vagus nerve stimulation will be applied to all participants with a VAGUSTIM device, biphasic, frequency 10 Hz, pulse width 300 μs in Modulation mode, and current intensity for 20 minutes for 10 sessions, keeping the current constant at the point where the participant feels the current comfortably. Before and after each application, pulse variability (rmssd, LF/HF, pNN50, LF, HF) and blood pressure measurements will be taken from both the right index finger and left index finger. Before the first session and after the 10th session, pain level will be evaluated with the Numerical Pain Rating Scale, and disability level related to headache will be evaluated with the Headache Impact Test.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals were divided into three groups as unilateral left, unilateral right and bilateral ear stimulations.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pulse Rate Variability; Pain