refractory chronic headache
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18-65 years. 2.chronic cluster headache, chronic transient unilateral neuralgia-like headache attacks with conjunctival congestion and tearing, chronic transient unilateral neuralgia-like headache attacks with autonomic symptoms of the head and face, chronic migraine, persistent migraine, chronic paroxysmal migraine, new onset daily persistent headache, and other chronic daily headaches that meet ICHD-3 diagnostic criteria. 3.Duration of illness = 24 months. 4.previous use of = 3 prophylactic medications alone or in combination (unless there are contraindications to drug use or unacceptable side effects) at optimal or maximum tolerated doses for a full course of treatment (2-3 months); poor outcome or only temporary relief from non-invasive treatments (e.g., Botox A injections, nerve blocks, transcranial magnetic stimulation, transcutaneous electrical stimulation of the occipital nerve, electrical stimulation of the vagus nerve, acupuncture, etc.) 5.basically normal neurological examination, except for certain headache-specific symptoms (e.g. Horner's syndrome in patients with chronic cluster headache, hypersensitivity or hyperalgesia of the face in patients with chronic SUNCT). 6.Basic normal cranial MRI plain + enhancement, MRV, MRA, skull base CT, and lumbar puncture, excluding brain injury, significant brain atrophy, or symptomatic headache. Subjects or their guardians are able to understand the purpose of the study, demonstrate adequate compliance with the study protocol, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications to MRI. 2.those with psychiatric disorders, severe cognitive impairment 3.the presence of cerebral infarction, hydrocephalus, severe atrophy of the thalamus, etc. affecting anatomical location or function, or surgical orientation 4.combination of any secondary headache or other chronic pain or other neurological disorders 5.medical and psychiatric contraindications, including: recent myocardial infarction, arrhythmia, stroke/stroke, autonomic disorders, endocrine disorders, uncontrolled/uncontrollable hypertension or hypotension with medication, epilepsy, other causes of deep brain irritation, degenerative central nervous dysfunction, severe electrolyte disturbances, etc. 6.Women during pregnancy or lactation. 7.Presence of contraindications to neurosurgery or anesthesia. 8.Subjects who have participated in any other drug or medical device clinical study within 3 months prior to screening. 9.Evidence of serious or uncontrollable systemic disease, as judged by the investigator. Subjects who, in the judgment of the investigator, are not suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced incidence of headache attacks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic response rate;No incidence of headache; | — |
Countries
China
Contacts
Chinese PLA General Hospital