Chronic Migraine, Headache Clinical Trial
Official title:
The Effect of Auricular Vagus Nerve Stimulation on Pain and Pulse Variability in Women With Migraine Disease
Verified date | February 2023 |
Source | Bahçesehir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 27, 2023 |
Est. primary completion date | June 20, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bahcesehir University | I?stanbul |
Lead Sponsor | Collaborator |
---|---|
Bahçesehir University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Blood Pressure | Blood pressure is the pressure that the heart creates on the vessel wall as it pumps blood through our body. | 1 month |
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