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Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

Primary Purpose

Chronic Migraine, Headache

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Auricular Vagus Nerve Stimulation
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine, Headache focused on measuring Pulse Rate Variability, Pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Bahcesehir University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Unilateral Right Ear

Unilateral Left Ear

Bilateral Ear

Arm Description

Auricular vagus nerve stimulation performed through the unilateral right ear.

Auricular vagus nerve stimulation performed through the unilateral left ear.

Auricular vagus nerve stimulation performed through the bilateral ear.

Outcomes

Primary Outcome Measures

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.
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).
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.
Blood Pressure
Blood pressure is the pressure that the heart creates on the vessel wall as it pumps blood through our body.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
February 20, 2023
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05748535
Brief Title
Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease
Official Title
The Effect of Auricular Vagus Nerve Stimulation on Pain and Pulse Variability in Women With Migraine Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache
Keywords
Pulse Rate Variability, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals were divided into three groups as unilateral left, unilateral right and bilateral ear stimulations.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral Right Ear
Arm Type
Experimental
Arm Description
Auricular vagus nerve stimulation performed through the unilateral right ear.
Arm Title
Unilateral Left Ear
Arm Type
Experimental
Arm Description
Auricular vagus nerve stimulation performed through the unilateral left ear.
Arm Title
Bilateral Ear
Arm Type
Experimental
Arm Description
Auricular vagus nerve stimulation performed through the bilateral ear.
Intervention Type
Device
Intervention Name(s)
Auricular Vagus Nerve Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
1 month
Title
Headache Impact Test (HIT-6)
Description
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).
Time Frame
1 month
Title
Pulse Variability/ Elite HRV Cor Sense Monitor
Description
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.
Time Frame
1 month
Title
Blood Pressure
Description
Blood pressure is the pressure that the heart creates on the vessel wall as it pumps blood through our body.
Time Frame
1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Since migraine is seen approximately 3 times more frequently in women than in men, a study consisting of a female population was planned.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bahcesehir University
City
İ̇stanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

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