Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

NCT05748535 | Completed DMC

• 1 other identifier: 21.04.2022/28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine, Headache

Keywords

Pulse Rate Variability; Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Unilateral Right Ear

EXPERIMENTAL

Auricular vagus nerve stimulation performed through the unilateral right ear.

Device: Auricular Vagus Nerve Stimulation

Unilateral Left Ear

EXPERIMENTAL

Auricular vagus nerve stimulation performed through the unilateral left ear.

Device: Auricular Vagus Nerve Stimulation

Bilateral Ear

EXPERIMENTAL

Auricular vagus nerve stimulation performed through the bilateral ear.

Device: Auricular Vagus Nerve Stimulation

Interventions

Auricular Vagus Nerve Stimulation DEVICE

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.

Bilateral Ear; Unilateral Left Ear; Unilateral Right Ear

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Since migraine is seen approximately 3 times more frequently in women than in men, a study consisting of a female population was planned.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Physiotherapist

Model Details: Individuals were divided into three groups as unilateral left, unilateral right and bilateral ear stimulations.

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 28, 2023
• Study Start: June 6, 2022
• Primary Completion: June 20, 2022
• Study Completion: January 27, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)