Migraine
Conditions
Interventions
2:trans auricular vagus nerve stimulation
Sponsors
the Seventh Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: ? Migraine (meeting the diagnostic criteria of the International Classification of Headache Disorders, 3rd Edition (ICHD-III beta) in 2013), regardless of gender. ? 18 years < age < 60 years. ? Not having participated in any biological, pharmacological, or medical device research or clinical trials within one month. ? capable of distinguishing migraine attacks from tension-type headache and cluster headache attacks. ? No significant abnormalities in major organ functions (heart, lungs, liver, and kidneys), or even if there are certain abnormalities, they do not have clinical significance. ? Signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1). Those with severe mental and behavioral abnormalities, cognitive impairment, and physical disabilities that prevent them from cooperating with the research project. (2). Those with significant organ dysfunction (chronic heart failure NYHA class III or above, pulmonary function MRC questionnaire grade 3 or above; ALT > 5 times the upper limit of normal, eGFR < 30 ml/min). (3). Those who have taken any catecholamine depleting agents, beta-blockers, alpha-blockers, or other autonomic nervous system drugs, antipsychotics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days. (4). Those with neurodegenerative diseases (such as Alzheimer's disease, Parkinson's disease/syndrome, multiple sclerosis, mitochondrial encephalomyopathy, motor neuron disease, etc.). (5). Those who need regular use of benzodiazepines to assist with sleep. (6). Those who are pregnant, have metal or electronic implants in their bodies, or have significant mental disorders, cognitive impairments, or claustrophobia that prevent them from cooperating with MRI examinations. (7). Those who are pregnant or breastfeeding. (8). Those who have received treatment for alcohol or drug abuse within 12 months (48 weeks) or have evidence of alcoholism or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| heart rate variability;dynamic pupillometry; | — |
Countries
China
Contacts
Public ContactQinghua Hou
Department of Neurology, Clinical Neuroscience Center. The seventh Affiliated Hospital, Sun Yat-sen University. Shenzhen, China
Outcome results
None listed