NCT05748535

Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

The Effect of Auricular Vagus Nerve Stimulation on Pain and Pulse Variability in Women With Migraine Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bahçeşehir University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Migraine, Headache

Interventions

Type	Name	Description
DEVICE	Auricular Vagus Nerve Stimulation	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.

Timeline

• Start date: 2022-06-06
• Primary completion: 2022-06-20
• Completion: 2023-01-27
• First posted: 2023-02-28
• Last updated: 2023-02-28

Locations

1 site across 1 country: Turkey (Türkiye)