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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Migraine, Headache
• Intervention / Treatment: Device: Auricular Vagus Nerve Stimulation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul, Turkey
    • Bahçeşehir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral Right Ear; Auricular vagus nerve stimulation performed through the unilateral right ear.	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.
Experimental: Unilateral Left Ear; Auricular vagus nerve stimulation performed through the unilateral left ear.	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.
Experimental: Bilateral Ear; Auricular vagus nerve stimulation performed through the bilateral ear.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	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.	1 month
Headache Impact Test (HIT-6)	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).	1 month
Pulse Variability/ Elite HRV Cor Sense Monitor	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.	1 month
Blood Pressure	Blood pressure is the pressure that the heart creates on the vessel wall as it pumps blood through our body.	1 month

Collaborators and Investigators

• Sponsor: Bahçeşehir University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Pulse Rate Variability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 21.04.2022/28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No