Chronic migraine
Conditions
Interventions
Experimental group:For the left DLPFC, the central frequency (f0) 500kHz, the pulse repetition frequency (PRF) is 100Hz, the duty cycle (DC) is 5%, the ultrasound duration (SD) is 500ms, the stimulati
Control group:The appearance, position, coupling medium and treatment time of the equipment are consistent with the test intervention
the output power is set to 0
the subject cannot see the parameters.
Sponsors
Chinese PLA General Hosptial
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with chronic migraine according to the IHS ICHD-3 guidelines and with a history of migraine for at least 12 months prior to the screening visit. 2. Patients had migraine attacks before the age of 50 (including 50). 3. Patients had a monthly headache duration of = 15 days within 3 months prior to the screening visit, and at least 8 of these days were identified as migraine days by the patients. 4. In the prospective collected electronic log information at the baseline period, patients meeting the following migraine criteria were included: = 8 days of migraine attacks, and headache attacks ranging from = 15 days to = 27 days. 5. Patients were compliant with the requirement of recording headache electronic logs, and recorded at least 24 days of data within 28 days after the screening visit. 6. At the screening visit, patients were aged between 18 and 65 years.
Exclusion criteria
Exclusion criteria: If the patient meets any of the following criteria, they will be excluded from this study: 1. Has a history of epilepsy, brain tumor or trauma. 2. Has a history of TMS, transcranial direct current stimulation or electroconvulsive therapy within the past 3 months. 3. Has metal implants such as arterial stents, cardiac pacemakers, ventriculo-peritoneal shunts, etc., and cannot undergo cranial MRI examination. 4. Has a mixed and clinically significant pain syndrome (such as fibromyalgia, chronic lower back pain, complex regional pain syndrome). 5. Has been diagnosed with acute or active temporomandibular disorders. 6. Has a history or diagnosis of chronic tension-type headache, sleep-related headache, cluster headache, persistent unilateral headache, new daily persistent headache or abnormal migraine subtypes, such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegia neuropathy, migraine with brainstem auras, and migraine with atypical migraine auras (double vision, altered consciousness or prolonged duration) accompanied by neurological associated symptoms (dizziness, altered consciousness or prolonged duration). 7. Took opioids or opioid-containing analgesics for more than 4 days before the baseline period or during the baseline period. 8. Has a history or diagnosis of failure in migraine prevention treatment using more than three of the following drug categories (drugs): Category 1: Sodium valproate, Sodium valproate Category 2: Topiramate Category 3: Beta-blockers (such as Metoprolol, Propranolol, Bisoprolol, etc.) Category 4: Tricyclic antidepressants (such as Amitriptyline, Desipramine, Protriptyline) Category 5: Flunarizine, Verapamil, Alprazolam Category 6: Serotonin-norepinephrine reuptake inhibitors (such as Venlafaxine, Desvenlafaxine, Duloxetine, Minoxidil) Category 7: Botulinum toxin Category 8: Lenvipril, Candesartan Category 9: Pregabalin, Gabapentin Category 10: Zonisamide Category 11: Memantine Category 12: Benztropine 9. Used devices or underwent surgical treatment for migraine within one month before the baseline period (such as transcranial magnetic stimulation, occipital nerve block, invasive or non-invasive neurostimulation surgery). Note: The study allows for patients who previously used preventive migraine medications or received acupuncture, herbal medicine treatment to have stable use for at least one month before the study and maintain consistency throughout the study. 10. Has a history of malignant tumors in any systemic organ (except localized basal cell carcinoma of the skin or stage 0 cervical cancer) in the past 5 years, regardless of whether treatment was received or whether there is evidence of local recurrence or metastasis. 11. Has a history of severe mental disorders (such as schizophrenia or other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder). For subjects with anxiety disorders and/or depression, if the researcher deems the disease state stable and the use of drugs for each disease does not exceed one type, such subjects can be included in the study. Subjects must maintain a stable dosage for at least 3 months before the baseline period. 12. SAS score >= 70; SDS score >= 72; BRMS score >= 6. 13. According to the C-SSRS questionnaire or based on the interview, the researcher considers there is a significant risk of self-harm or harm to others. If a participant has had suicidal thoughts and intentions within the last 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the observation period (baseline period) of the monthly migraine day of follow-up visit for 1 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the relative observation period in the number of days of using any acute headache drug per month during the follow-up period;The proportion of patients with monthly migraine days decreased by at least 50% and 75% during follow-up for 1 month.;Changes in the relative observation period of monthly moderate and severe headache days during follow-up for 1 month;Changes in the visual simulation score (VAS) from each intervention to 1 month of follow-up;Changes in the relative observation period of the most disturbing symptoms (MBS) every month between the entire intervention period and one month of follow-up;Changes in the total score, absenteeism and invalid attendance score of the monthly migraine failure assessment (mMIDAS) questionnaire after the last intervention and 1 month of follow-up compared with the observation period;After the last intervention and 1 month of follow-up, the role function of the migraine-specific quality of life questionnaire (MSQ V2.1) - changes in the prevention dimension and emotional function dimension score compared with the observation period;Changes in the score of the headache impact test (HIT-6) compared with the observation period within 1 month after the last intervention and follow-u;Patient's overall impression (PGI-C) score after the last intervention and 1 month of follow-up;Changes in the score of 9 patient health questionnaires (PHQ-9) compared with the observation period after the last intervention and 1 month of follow-up;Changes in the scores of the 7-item generalised anxiety disorder scale (GAD-7) compared with the observation period after the last intervention and 1 month of follow-up; | — |
Countries
China
Contacts
Public ContactShengyuan Yu;Zhao Dong
Chinese PLA General Hospital
Outcome results
None listed