Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

Bahçeşehir University

Status: Completed

Conditions: Chronic Migraine, Headache

Treatments: Device: Auricular Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05748535

21.04.2022/28

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People between the ages of 18-55 with migraine disease
• Having a definite diagnosis of migraine by a neurologist
• Absence of any orthopedic, neurological, etc. diseases that will prevent physical activity
• Not using drugs continuously except for migraine attacks
• Willingness to participate in the study
• Having signed the informed consent form

Exclusion criteria

• Cases do not want to continue the study.
• Not signing the informed consent form
• Being on medication for migraine prophylaxis
• Having a communication problem that does not allow evaluation
• Having a history of additional chronic disease that interferes with physical activity,
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Unilateral Right Ear

Experimental group

Description:

Auricular vagus nerve stimulation performed through the unilateral right ear.

Treatment:

Device: Auricular Vagus Nerve Stimulation

Unilateral Left Ear

Experimental group

Description:

Auricular vagus nerve stimulation performed through the unilateral left ear.

Treatment:

Device: Auricular Vagus Nerve Stimulation

Bilateral Ear

Experimental group

Description:

Auricular vagus nerve stimulation performed through the bilateral ear.

Treatment:

Device: Auricular Vagus Nerve Stimulation