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Deep Brain Stimulation for Precise Treatment of Refractory Headache

The clinical research of deep brain stimulation for refractory chronic headache

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062135
Enrollment
Unknown
Registered
2022-07-24
Start date
2022-07-31
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory chronic headache

Interventions

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime frame
Reduced incidence of headache attacks;

Secondary

MeasureTime frame
Therapeutic response rate;No incidence of headache;

Countries

China

Contacts

Public ContactDong Zhao

Chinese PLA General Hospital

dong_zhaozhao@126.com+86 010 55499218

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026