Clinical trial NCT05748535: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine, Headache
Keywords: Pulse Rate Variability
Pain
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals were divided into three groups as unilateral left, unilateral right and bilateral ear stimulations.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 1 month
measure: Headache Impact Test (HIT-6)
timeFrame: 1 month
measure: Pulse Variability/ Elite HRV Cor Sense Monitor
timeFrame: 1 month
measure: Blood Pressure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Bahcesehir University
Study officials:
References: