Chronic Migraine HeadacheNCT07395908
The Effect of Interventional Procedures on Serum CGRP and PACAP-38 Levels in Chronic Migraine
A study testing Greater occipital nerve Pulse radiofrequency and Greater occipital nerve block in people with Chronic Migraine Headache and Radiofrequency Ablation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The study included 100 patients diagnosed with chronic migraine (CM) who received a diagnosis from the headache clinics of the Neurology Department of Adnan Menderes University Hospitals between May 2025 and May 2026. Inclusion criteria were patients over 18 years of age with chronic migraine. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine Headache, Radiofrequency Ablation, Greater Occipital Nerve Block
- What is being tested?
- Greater occipital nerve Pulse radiofrequency and Greater occipital nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2025to Jun 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Having given written consent
- Patients diagnosed with chronic migraine
Who cannot join
- Major psychiatric illness
- Patients using anticoagulant agents
- 4. Patients with infection in the procedure area 5. Patients allergic to local anesthetics 6. Pregnant women 7. Patients with cardiac pacemakers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Efeler / Aydın
Aydin, 09100
About this study
Official title: Comparison of the Effectiveness of Trigeminocervical Complex Peripheral Branch Blockade and Neuromodulation Methods With Peripheral Blood CGRP and PACAP38 Levels in Patients With Chronic Migraine
The study included 100 patients diagnosed with chronic migraine (CM) who received a diagnosis from the headache clinics of the Neurology Department of Adnan Menderes University Hospitals between May 2025 and May 2026. Inclusion criteria were patients over 18 years of age with chronic migraine. Written informed consent was obtained from all participants; patients with severe systemic diseases, occiput infections or injuries, and allergies to any of the substances used in the injection were excluded. All patients were clinically evaluated (detailed history including personal data, medical history, and migraine treatments used). All patients underwent ultrasound-guided bilateral GON blockade using a portable ultrasound system with a 7-13 MHz multifrequency transducer (ACUSON Juniper Ultrasound System, Siemens, Germany). Blood samples were collected before and one month after the procedure. Samples were collected between 9 and 11 am to avoid the effect of circadian rhythms on CGRP levels. Patients will need to discontinue any anti-inflammatory or analgesic medication within the last 48 hours. A blood sample will be taken from the non-dominant forearm to measure interictal serum CGRP-PACAP38 levels using commercial ELISA kits (Novus Biologicals Inc., USA) according to the manufacturer's instructions. Absorption levels will be measured with a spectrophotometer at a wavelength of 450 nm ± 2 nm. The detection limit for CGRP is 9.3 pg/mL.
Read the detailed description
Preoperative Visit:
During the preoperative visit, patients' additional illnesses, demographic data, and medication use will be recorded. The patients' NRS (Numerating Rating Scale) score will be recorded. Antebrachial venous blood samples will be taken along with routine samples requested after the outpatient examination.
Intraoperative Nerve Block Procedure:
All procedures were planned to be performed under sterile conditions with ultrasound guidance while the patient was in the prone position.
GON Block: The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.
Intraoperative Pulse Radiofrequency procedure:
For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 seconds.
Patients will be observed after the procedure. Patients who do not experience postoperative complications and are mobile will be discharged at 2 hours. Patients may withdraw from the study at any time.
Patients meeting the eligibility criteria will be informed in detail about the procedure. Written and verbal consent will be obtained from the patients.
Post-operative visits:
Venous blood sampling will be performed one month after the procedure, along with routine samples requested after the outpatient examination.
Samples were collected between 9 and 11 a.m. to avoid the influence of circadian rhythms on CGRP levels. Subjects were required to discontinue any anti-inflammatory or analgesic medication in the previous 48 hours. Blood samples were taken from the non-dominant forearm to measure interictal serum CGRP levels using commercial ELISA kits (Novus Biologicals Inc., USA) following the manufacturer's instructions. Absorption levels were measured with a spectrophotometer at a wavelength of 450 nm to 2 nm. The detection limit of the test was considered to be 9.3 pg/ml for CGRP.
For PACAP 38, blood samples were collected into ice-cold glass tubes containing the anticoagulant ethylenediaminetetraacetic acid (EDTA, 12 mg) and the protease inhibitor aprotinin (Trasylol, 1200 IU) and kept at 4°C until centrifuged (2000 rpm for 10 minutes at 4°C). Plasma samples will be stored at -80°C until measured by PACAP-38.
Pain intensity will be assessed using the NRS (Numerical Rating Scale) at 1, 3, and 6 months post-procedure.
The NRS is a pain intensity assessment system based on a system where the individual describes their pain on a scale of 0 (none) to 10 (unbearable pain).
- Conditions
- Chronic Migraine Headache, Radiofrequency Ablation, Greater Occipital Nerve Block, Calcitonin Gene-related Peptide, Pacap-38
- Being tested
- Greater occipital nerve Pulse radiofrequency, Greater occipital nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater occipital nerve Pulse radiofrequencyProcedure or surgery
For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 seconds.
Greater occipital nerve blockProcedure or surgery
The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.
| Study group | Role | What they receive |
|---|---|---|
| patients to whom applied radiofrequency | Experimental | For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 second Receives: Procedure: Greater occipital nerve Pulse radiofrequency |
| patients to whom applied greater occipital nerve block | Active comparator | The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique. Receives: Procedure: Greater occipital nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers
It was planned to measure venous blood CGRP and PACAP38 levels in patients with chronic migraine before the interventional procedure and one month after the procedure.
Measured: 1 month
Secondary outcomes (1)
The secondary outcome of this study is to compare the effectiveness of nerve block and radiofrequency treatments on chronic pain in patients with chronic migraine.
To evaluate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine, a numerical rating scale (NRS) was planned to be applied before the procedure, and at 1, 3, and 6 months after the procedure. An NRS reduction of 50% or more was considered significant.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start29 May 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ertilav, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395908
- Sponsor's protocol ID
- 2025/153
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Trigeminocervical Complex Peripheral Branch Blockade and Neuromodulation Methods With Peripheral Blood CGRP and PACAP38 Levels in Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT07395908
- Acronym / sponsor ID
- 2025/153
- Conditions
- Chronic Migraine Headache, Radiofrequency Ablation, Greater Occipital Nerve Block, Calcitonin Gene-related Peptide, Pacap-38
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
The study included 100 patients diagnosed with chronic migraine (CM) who received a diagnosis from the headache clinics of the Neurology Department of Adnan Menderes University Hospitals between May 2025 and May 2026. Inclusion criteria were patients over 18 years of age with chronic migraine. Written informed consent was obtained from all participants; patients with severe systemic diseases, occiput infections or injuries, and allergies to any of the substances used in the injection were excluded. All patients were clinically evaluated (detailed history including personal data, medical history, and migraine treatments used). All patients underwent ultrasound-guided bilateral GON blockade using a portable ultrasound system with a 7-13 MHz multifrequency transducer (ACUSON Juniper Ultrasound System, Siemens, Germany). Blood samples were collected before and one month after the procedure. Samples were collected between 9 and 11 am to avoid the effect of circadian rhythms on CGRP levels. Patients will need to discontinue any anti-inflammatory or analgesic medication within the last 48 hours. A blood sample will be taken from the non-dominant forearm to measure interictal serum CGRP-PACAP38 levels using commercial ELISA kits (Novus Biologicals Inc., USA) according to the manufacturer's instructions. Absorption levels will be measured with a spectrophotometer at a wavelength of 450 nm ± 2 nm. The detection limit for CGRP is 9.3 pg/mL.
Detailed description
Preoperative Visit:
During the preoperative visit, patients' additional illnesses, demographic data, and medication use will be recorded. The patients' NRS (Numerating Rating Scale) score will be recorded. Antebrachial venous blood samples will be taken along with routine samples requested after the outpatient examination.
Intraoperative Nerve Block Procedure:
All procedures were planned to be performed under sterile conditions with ultrasound guidance while the patient was in the prone position.
GON Block: The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.
Intraoperative Pulse Radiofrequency procedure:
For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 seconds.
Patients will be observed after the procedure. Patients who do not experience postoperative complications and are mobile will be discharged at 2 hours. Patients may withdraw from the study at any time.
Patients meeting the eligibility criteria will be informed in detail about the procedure. Written and verbal consent will be obtained from the patients.
Post-operative visits:
Venous blood sampling will be performed one month after the procedure, along with routine samples requested after the outpatient examination.
Samples were collected between 9 and 11 a.m. to avoid the influence of circadian rhythms on CGRP levels. Subjects were required to discontinue any anti-inflammatory or analgesic medication in the previous 48 hours. Blood samples were taken from the non-dominant forearm to measure interictal serum CGRP levels using commercial ELISA kits (Novus Biologicals Inc., USA) following the manufacturer's instructions. Absorption levels were measured with a spectrophotometer at a wavelength of 450 nm to 2 nm. The detection limit of the test was considered to be 9.3 pg/ml for CGRP.
For PACAP 38, blood samples were collected into ice-cold glass tubes containing the anticoagulant ethylenediaminetetraacetic acid (EDTA, 12 mg) and the protease inhibitor aprotinin (Trasylol, 1200 IU) and kept at 4°C until centrifuged (2000 rpm for 10 minutes at 4°C). Plasma samples will be stored at -80°C until measured by PACAP-38.
Pain intensity will be assessed using the NRS (Numerical Rating Scale) at 1, 3, and 6 months post-procedure.
The NRS is a pain intensity assessment system based on a system where the individual describes their pain on a scale of 0 (none) to 10 (unbearable pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients to whom applied radiofrequency | Experimental | Procedure: Greater occipital nerve Pulse radiofrequencyFor radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 second |
| patients to whom applied greater occipital nerve block | Active comparator | Procedure: Greater occipital nerve blockThe ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Having given written consent
- Patients diagnosed with chronic migraine
Key exclusion criteria (3 listed)
- Major psychiatric illness
- Patients using anticoagulant agents
- 4. Patients with infection in the procedure area 5. Patients allergic to local anesthetics 6. Pregnant women 7. Patients with cardiac pacemakers
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 |
|---|---|---|
| Greater occipital nerve Pulse radiofrequencyFor radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 seconds. | Procedure or surgery | patients to whom applied radiofrequency |
| Greater occipital nerve blockThe ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique. | Procedure or surgery | patients to whom applied greater occipital nerve block |
Primary outcome
The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers
Time frame: 1 month
It was planned to measure venous blood CGRP and PACAP38 levels in patients with chronic migraine before the interventional procedure and one month after the procedure.
1 secondary outcome
The secondary outcome of this study is to compare the effectiveness of nerve block and radiofrequency treatments on chronic pain in patients with chronic migraine.
Time frame: 6 months
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 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greater occipital nerve Pulse radiofrequency and Greater occipital nerve block in people with Chronic Migraine Headache and Radiofrequency Ablation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers (time frame: 1 month). 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 9 Feb 2026.