Migraine
Conditions
Interventions
Treatment group:Electrical stimulation of the sphenopalatine ganglion
Sponsors
Shenzhen Nanshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects were between the ages of 18 and 70, male and female, mentally normal and conscious. 2.Subjects had no abnormalities on cranial MRI or CT, no previous history of head trauma, and a negative neurological examination. 3.Subjects were diagnosed as suffering from migraine with or without aura according to 2018 ICHD-3 diagnostic criteria 1.1 and 1.2.1.1. 4.Subjects had a MIDAS grade of III or IV, or a HIT-6 score > 56. 5.Subjects agree not to participate in complementary or alternative treatments during the baseline or treatment phase of the clinical study. This includes: acupuncture, TENS and magnetic field therapy.
Exclusion criteria
Exclusion criteria: 1. Subjects had been diagnosed with TACs or a history of trigeminal neuralgia. 2. Subjects had undergone SPG block or radiofrequency ablation within the past 3 months. 3. Subjects had received head and neck botulinum toxin A injections or CGRP inhibitors within the past 3 months. 4. Subjects with preoperative puncture site infections or coagulation disorders. 5. Subjects were women of childbearing age who were pregnant, breastfeeding or not using contraception. 6. Subjects who, in the judgement of the investigator, are unsuitable for the study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in number of migraine days per month relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Migraine Disability Assessment (MIDAS) questionnaire scores;Safety;Changes in headache severity;Changes in headache impact test (HIT-6) scores;Changes in headache duration;Changes in pittsburgh sleep quality index (PSQI) scores;Changes in frequency of headache attacks;Use of pain medication; | — |
Countries
China
Contacts
Public ContactYuhui Luo
Shenzhen Nanshan People's Hospital
Outcome results
None listed