Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

Not Applicable

Completed

• Conditions: Chronic Migraine, Headache
• Interventions: Device: Auricular Vagus Nerve Stimulation

• Registration Number: NCT05748535
• Lead Sponsor: Bahçeşehir University

Brief 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.

Study Timeline

• Study Start: 2022-06-06
• Primary Completion: 2022-06-20
• Study Completion: 2023-01-27
• Status Verified: 2023-02
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral Left Ear	Auricular Vagus Nerve Stimulation	Auricular vagus nerve stimulation performed through the unilateral left ear.
Bilateral Ear	Auricular Vagus Nerve Stimulation	Auricular vagus nerve stimulation performed through the bilateral ear.
Unilateral Right Ear	Auricular Vagus Nerve Stimulation	Auricular vagus nerve stimulation performed through the unilateral right ear.

Primary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale	1 month	The Numerical Pain Rating Scale is a widely used scale that requires the patient to rate their pain on a scale of 0 to 10; 0 indicates no pain and 10 reflects the worst possible pain.
Headache Impact Test (HIT-6)	1 month	It is a short questionnaire designed to evaluate migraine pain from the patient's perspective and to track the time lost by the patient due to migraine (work, school, housework, social activities).
Pulse Variability/ Elite HRV Cor Sense Monitor	1 month	CorSense HRV monitors are used in this study Elite HRV purchased from the company. Readings will be collected through the Elite HRV app designed for mobile devices. The platform is R-R registered via industry standard, according to the Elite HRV website. ranges and defines 0.04-0.15 Hz waves as LF and 0.15-0.40 Hz waves as HF.
Blood Pressure	1 month	Blood pressure is the pressure that the heart creates on the vessel wall as it pumps blood through our body.

Trial Locations

Locations (1)

Bahcesehir University; 🇹🇷 İ̇stanbul, Turkey