Chronic MigraineNCT06322407
Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult
A study testing Stellate Ganglion Block (SGB) and standardized drug treatment in people with Chronic Migraine, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Stellate Ganglion Block (SGB) and standardized drug treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years;
- 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].
- 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.
Who cannot join
- BMI <15 kg/m2 or >35 kg/m2；
- Previous SGB treatment；
- History of other neurological disorders；
- History of severe cardiopulmonary, hepatic or renal dysfunction；
- History of allergies to any of the study drugs；
- Patients with chronic use of opioids；
Show all 12Show fewer
- Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)；
- Infection or mass near the puncture site；
- Neck anatomic structural changes (caused by radiotherapy or surgery);
- Pregnant or breast feeding;
- Psychological disorders;
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Fang Luo, M.D, +86 13611326978, 13611326978@163.com
Lu Liu, +86 18618418228, emmaliulu@163.com
About this study
Official title: A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment
To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy.
Read the detailed description
The investigators aim to investigate whether the stellate ganglion block(SGB) is better than traditional medication treatment and provides medical evidence for the clinical application and promotion of SGB to provide a minimally invasive, safe, and effective treatment for patients with chronic migraine(CM) who failed to receive standardized drug treatment.
- Conditions
- Chronic Migraine
- Being tested
- Stellate Ganglion Block (SGB), standardized drug treatment
- Keywords
- Chronic Migraine, Stellate Ganglion Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion Block (SGB)Procedure or surgery
Also called Ultrasound-guided Stellate Ganglion Block (SGB)
All SGB procedures will be performed by the same experienced physicians. Patients will be positioned in a supine position with the neck slightly hyperextended and receive a SGB procedure using the B-ultrasound visualization technique (Aurora A5 Ultrasound, Risco Tech Co., Ltd.). 1% lidocaine 5mL (Shanxi Jinxin Shuanghe Pharm Co., Ltd.) will be injected below the prevertebral fascia on the surface of longus colli muscle
standardized drug treatmentDrug
Also called topiramate plus ibuprofen
Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block plus standardized drug treatment group | Experimental | Besides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side; Receives: Procedure: Stellate Ganglion Block (SGB); Drug: standardized drug treatment |
| standardized drug treatment group | Active comparator | The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM. Receives: Drug: standardized drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline in mean monthly migraine days
The primary outcome is the change from baseline in mean monthly (defined as 4 weeks) migraine days across 6-months follow-up period, which will be assessed by a blinded independent central review (BICR). Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A migraine day is defined as a calendar day with symptoms of a migraine attack lasting at least 30 min.
Measured: 6-month period
Secondary outcomes (8)
Proportion of patients achieved≥50% reduction in monthly migraine days
Proportion of patients achieved≥50% reduction
Measured: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Total effective rate
Total effective rate = cure rate + markedly effective rate + effective rate
Measured: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The mean Numeric Rating Scale(NRS) score during headache attack
The Numeric Rating Scale(NRS) scoring method typically uses a score range of 0-10, with 0 indicating no pain or symptoms and 10 indicating the most severe pain or symptoms.
Measured: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Patients satisfaction (PS)
Patients satisfaction (PS) evaluated by PS scores, which typically uses a score range of 0-10, with 0 indicating no patient satisfaction and 10 indicating the most patient satisfaction.
Measured: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The six item headache impact test (HIT-6)
The six item headache impact test (HIT-6) is a self-reported questionnaire measuring the "impact that headaches have on the ability to function on the job, at school, at home, and in social situations.
Measured: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
the Migraine Disability Assessment score(MIDAS)
MIDAS is a reliable and validated scale measuring migraine-related disability regarding the need for medical care.. Higher MIDAS scores indicate more days with disability
Measured: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-administered assessment of sleep disturbances that may affect sleep quality, including sleep apnoea, with a higher score indicating more severe sleep disturbances.
Measured: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
adverse events
Proportion of participants with adverse events (AEs) and serious adverse events
Measured: at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322407
- Sponsor's protocol ID
- KY2023-263-03-02
- Status last verified
- Jan 2025
- First submitted
- 11 Mar 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment
- ClinicalTrials.gov ID
- NCT06322407
- Acronym / sponsor ID
- KY2023-263-03-02
- Conditions
- Chronic Migraine
- Keywords
- Chronic Migraine, Stellate Ganglion Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy.
Detailed description
The investigators aim to investigate whether the stellate ganglion block(SGB) is better than traditional medication treatment and provides medical evidence for the clinical application and promotion of SGB to provide a minimally invasive, safe, and effective treatment for patients with chronic migraine(CM) who failed to receive standardized drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block plus standardized drug treatment group | Experimental | Procedure: Stellate Ganglion Block (SGB), Drug: standardized drug treatmentBesides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side; |
| standardized drug treatment group | Active comparator | Drug: standardized drug treatmentThe patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 65 years;
- 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].
- 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.
Key exclusion criteria (12 listed)
- BMI <15 kg/m2 or >35 kg/m2；
- Previous SGB treatment；
- History of other neurological disorders；
- History of severe cardiopulmonary, hepatic or renal dysfunction；
- History of allergies to any of the study drugs；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion Block (SGB)Also: Ultrasound-guided Stellate Ganglion Block (SGB)All SGB procedures will be performed by the same experienced physicians. Patients will be positioned in a supine position with the neck slightly hyperextended and receive a SGB procedure using the B-ultrasound visualization technique (Aurora A5 Ultrasound, Risco Tech Co., Ltd.). 1% lidocaine 5mL (Shanxi Jinxin Shuanghe Pharm Co., Ltd.) will be injected below the prevertebral fascia on the surface of longus colli muscle | Procedure or surgery | Stellate Ganglion Block plus standardized drug treatment group |
| standardized drug treatmentAlso: topiramate plus ibuprofenTopiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache. | Drug | Stellate Ganglion Block plus standardized drug treatment group, standardized drug treatment group |
Primary outcome
the change from baseline in mean monthly migraine days
Time frame: 6-month period
The primary outcome is the change from baseline in mean monthly (defined as 4 weeks) migraine days across 6-months follow-up period, which will be assessed by a blinded independent central review (BICR). Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A migraine day is defined as a calendar day with symptoms of a migraine attack lasting at least 30 min.
8 secondary outcomes
Proportion of patients achieved≥50% reduction in monthly migraine days
Time frame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Total effective rate
Time frame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The mean Numeric Rating Scale(NRS) score during headache attack
Time frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Patients satisfaction (PS)
Time frame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The six item headache impact test (HIT-6)
Time frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
the Migraine Disability Assessment score(MIDAS)
Time frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
adverse events
Time frame: at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block (SGB) and standardized drug treatment in people with Chronic Migraine, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline in mean monthly migraine days (time frame: 6-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.