Headache, ClusterNCT06787677
SPG Pulsed Radiofrequency for Chronic Cluster Headache
A study testing PRF and NB in people with Headache, Cluster, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Cluster
- What is being tested?
- PRF and NB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2025to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic cluster headache;
- At least four attacks per week;
- Minimum age of 18 years;
- Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.
Who cannot join
- Pregnancy or breastfeeding;
- Presence of cardiac pacemaker or other neuromodulatory devices;
- Pyschiatric and cognitive disorders;
- Serious drug habituation or overuse of acute-headache medication;
- History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;
- Infection at the puncture site;
- Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.
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
Fang Luo
Beijing, Beijing Municipality, 100070
Fang Luo, 59976661, 13611326978@163.com
About this study
Official title: The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.
- Conditions
- Headache, Cluster
- Being tested
- PRF, NB
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFProcedure or surgery
After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms.
NBProcedure or surgery
After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| PRF group | Experimental | Not described Receives: Procedure: PRF |
| Nerve Block Group | Active comparator | Not described Receives: Procedure: NB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean attack frequency in the last 4 weeks (week 8-12) after procedure
The overall mean change from baseline in mean weekly attack frequency
Measured: In the last 4 weeks (week 8-12) after procedure
Secondary outcomes (7)
Mean attack frequency
Mean change in mean attack frequency
Measured: From baseline to each 4-week interval through 1 year after procedure
50% reduction of mean attack frequency
Percentage of patients with a 50% reduction in mean attack frequency
Measured: From baseline to each 4-week interval through 1 year after procedure
30% reduction of mean attack frequency
Percentage of patients with a 30% reduction in mean attack frequency
Measured: From baseline to each 4-week interval through 1 year after procedure
Patient Global Impression of Improvement
Percentage of patients reporting a score of 1 (''very much better'') or 2 (''much better'')
Measured: At month 1, month 2, month 3, month 6, and month 12 after procedure
Mean attack intensity
0-10 on the numeric rating scale, with 0 equating no pain and 10 the worst pain possible
Measured: From baseline to each 4-week interval through 1 year after procedure
Patient satisfaction scores
0 point indicates unsatisfied to 10 points indicate very satisfied. The higher the score, the more dissatisfied the patient is.
Measured: At month 1, month 2, month 3, month 6, and month 12 after procedure
The incidence of perioperative adverse events
Perioperative adverse events (AEs) including headache, dizziness, nausea, vomiting, facial hematoma, and numbness in the area innervated by the maxillary nerve
Measured: Across 1 year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start24 Jan 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Headache, ClusterStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 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
- NCT06787677
- Sponsor's protocol ID
- KY 2018-027-02-1
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Publications
Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9.
PubMed 31701891Schoenen J, Snoer AH, Brandt RB, Fronczek R, Wei DY, Chung CS, Diener HC, Dodick DW, Fontaine D, Goadsby PJ, Matharu MS, May A, McGinley JS, Tepper SJ, Jensen RH, Ferrari MD; IHS Standing Committee for Clinical Trials; IHS cluster headache trial guideline subcommittee. Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache. Cephalalgia. 2022 Dec;42(14):1450-1466. doi: 10.1177/03331024221120266. Epub 2022 Oct 21.
PubMed 36268950Wilbrink LA, de Coo IF, Doesborg PGG, Mulleners WM, Teernstra OPM, Bartels EC, Burger K, Wille F, van Dongen RTM, Kurt E, Spincemaille GH, Haan J, van Zwet EW, Huygen FJPM, Ferrari MD; ICON study group. Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial. Lancet Neurol. 2021 Jul;20(7):515-525. doi: 10.1016/S1474-4422(21)00101-0.
PubMed 34146510
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
- ClinicalTrials.gov ID
- NCT06787677
- Acronym / sponsor ID
- KY 2018-027-02-1
- Conditions
- Headache, Cluster
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jan 2025 (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.
Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF group | Experimental | Procedure: PRF |
| Nerve Block Group | Active comparator | Procedure: NB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic cluster headache;
- At least four attacks per week;
- Minimum age of 18 years;
- Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding;
- Presence of cardiac pacemaker or other neuromodulatory devices;
- Pyschiatric and cognitive disorders;
- Serious drug habituation or overuse of acute-headache medication;
- History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;
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 |
|---|---|---|
| PRFAfter the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms. | Procedure or surgery | PRF group |
| NBAfter the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine. | Procedure or surgery | Nerve Block Group |
Primary outcome
The mean attack frequency in the last 4 weeks (week 8-12) after procedure
Time frame: In the last 4 weeks (week 8-12) after procedure
The overall mean change from baseline in mean weekly attack frequency
7 secondary outcomes
Mean attack frequency
Time frame: From baseline to each 4-week interval through 1 year after procedure
50% reduction of mean attack frequency
Time frame: From baseline to each 4-week interval through 1 year after procedure
30% reduction of mean attack frequency
Time frame: From baseline to each 4-week interval through 1 year after procedure
Patient Global Impression of Improvement
Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure
Mean attack intensity
Time frame: From baseline to each 4-week interval through 1 year after procedure
Patient satisfaction scores
Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure
The incidence of perioperative adverse events
Time frame: Across 1 year after procedure
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 27 Jan 2025.
- Background: PubMed 31701891Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9.
- Results publication: PubMed 36268950Schoenen J, Snoer AH, Brandt RB, Fronczek R, Wei DY, Chung CS, Diener HC, Dodick DW, Fontaine D, Goadsby PJ, Matharu MS, May A, McGinley JS, Tepper SJ, Jensen RH, Ferrari MD; IHS Standing Committee for Clinical Trials; IHS cluster headache trial guideline subcommittee. Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache. Cephalalgia. 2022 Dec;42(14):1450-1466. doi: 10.1177/03331024221120266. Epub 2022 Oct 21.
- Results publication: PubMed 34146510Wilbrink LA, de Coo IF, Doesborg PGG, Mulleners WM, Teernstra OPM, Bartels EC, Burger K, Wille F, van Dongen RTM, Kurt E, Spincemaille GH, Haan J, van Zwet EW, Huygen FJPM, Ferrari MD; ICON study group. Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial. Lancet Neurol. 2021 Jul;20(7):515-525. doi: 10.1016/S1474-4422(21)00101-0.
- Individual participant dataSharing planned: Yes. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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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 PRF and NB in people with Headache, Cluster, 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 4 inclusion and 7 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 27 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?
Contact Fang Luo (59976661, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean attack frequency in the last 4 weeks (week 8-12) after procedure (time frame: In the last 4 weeks (week 8-12) after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787677, which also lists 3 linked publications.
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 27 Jan 2025.