Using ultrasound to block a nerve for treating chronic migraines
A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment
NA · Beijing Tiantan Hospital · NCT06322407
This study is testing if using ultrasound to block a specific nerve can help adults with chronic migraines who haven't found relief from regular treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06322407 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of ultrasound-guided stellate ganglion block (SGB) as a treatment for adults suffering from chronic migraines who have not found relief from standard preventive therapies. The goal is to determine if SGB can provide a better alternative to traditional medication treatments, offering a minimally invasive and effective solution. Participants will be monitored over a six-month period to assess the outcomes of this intervention compared to standardized drug treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with chronic migraines who have failed or are unsuitable for up to three previous preventive treatments.
Not a fit: Patients with a history of severe neurological disorders, significant cardiopulmonary issues, or those who have previously undergone SGB treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients with chronic migraines who have not responded to conventional therapies.
How similar studies have performed: While the use of stellate ganglion block for chronic migraines is a relatively novel approach, preliminary studies have shown promising results in similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age from 18 to 65 years; 2. Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria \[Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211\]. 3. not received prior prophylactic migraine treatment or, due to lack of efficacy or tolerability, had failed or had not been suitable for up to three previous prophylactic treatments from the following: Metoprolol/propranolol, amitriptyline, and flunarizine. Exclusion Criteria: 1. BMI \<15 kg/m2 or \>35 kg/m2； 2. Previous SGB treatment； 3. History of other neurological disorders； 4. History of severe cardiopulmonary, hepatic or renal dysfunction； 5. History of allergies to any of the study drugs； 6. Patients with chronic use of opioids； 7. Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)； 8. Infection or mass near the puncture site； 9. Neck anatomic structural changes (caused by radiotherapy or surgery); 10. Pregnant or breast feeding; 11. Psychological disorders; 12. Refusal to sign informed consent.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Migraine, Stellate Ganglion Block