Chronic Migraine, HeadacheNCT07500558
Ultrasound Guided Infratemporal Sphenopalatine Ganglion Supravoltage Versus Standard Voltage Pulsed Radiofrequency for Pain Alleviation in Chronic Refractory Migraine.
A study testing Standarad PRF and Supravoltage PRF in people with Chronic Migraine, Headache, run by Minia University at 2 sites in Egypt.
Trial summary
PRF performed on the sphenopalatine ganglion level under ultrasound guidance. Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Migraine, Headache
- What is being tested?
- Standarad PRF and Supravoltage PRF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 31 Mar 2026to 2 Apr 2027
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic migraine according to International Classification of Headache Disorders criteria (≥15 headache days/month for >3 months, including ≥8 migraine days/month) documented by Completion of 4-week prospective baseline headache diary immediately preceding randomization
- Failure of ≥2 classes of preventive pharmacological migraine medications (e.g., beta-blockers, antiepileptics, antidepressants...) to get clinically meaningful response ( defined as ≥50% reduction in monthly migraine days), at standard therapeutic doses (Beta-blockers (e.g., propranolol ≥160 mg/day, metoprolol ≥100 mg/day, Antiepileptics (e.g., topiramate ≥100 mg/day, valproate ≥500 mg/day, Tricyclic antidepressants (e.g., amitriptyline ≥50 mg/day, SNRIs (e.g., venlafaxine ≥150 mg/day ) for at least 8 weeks or ≥12 weeks in case of CGRP ).
- Stable preventive migraine therapy for at least 4 weeks prior to enrollment.
- MIDAS score ≥11 indicating moderate to severe disability.
- Ability and willingness to maintain a daily headache diary throughout the study period.
- Ability to provide written informed consent. Positive response (≥50% pain reduction within 30-60 minutes) to diagnostic INFRATEMPORAL sphenopalatine ganglion block using 2% lidocaine (2 mL) infrazygomatic approach
Who cannot join
- Medication Overuse Headache per ICHD-3: Simple analgesics (acetaminophen, NSAIDs, non-opioid analgesics) used on ≥15 days per month for >3 months, OR Triptans, ergot derivatives, opioids, or combination analgesics used on ≥10 days per month for >3 months.
- Any secondary headache disorder ( cluster headache, hemiplegic migraine, migraine with brainstem aura (distinct pathophysiology); chronic tension-type headache >10 days/month.
- Any prior SPG block, PRF, radiofrequency thermocoagulation, chemical neurolysis, or neurostimulation of SPG/trigeminal system within 6 month.
- No prior occipital or supra-orbital nerve radiofrequency, cryotherapy, or chemical neurolysis within 3 months
- Use of botulinum toxin (Botox) within 3 months or CGRP monoclonal antibodies within 3 months prior to enrollment.
- Active psychosis, bipolar disorder (current manic/depressive episode), severe depression with suicidal ideation, dementia, or substance use disorder (DSM-5 criteria) within 12 months; PHQ-9 ≥20 or cognitive impairment affecting reporting reliability.
Show all 11Show fewer
- Cardiac pacemaker, ICD, neurostimulator, or cochlear implant; or ECT.
- Chronic uncontroled hypertension ; history of stroke, intracranial aneurysm, or high risk for cardiovascular events.
- Pregnancy or lactation, Initiation, discontinuation, or modification of hormonal contraceptive therapy within 3 months prior to enrollment.
- Coagulopathy (platelets <100,000 or INR >1.5) or ongoing anticoagulation not safely withheld.
- -Patient refusal.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Minia university raouf
Minya, 61511
Minia university raouf, 01015752424, drmina2015@gmail.com
01015752424
- Recruiting
Minia university
Minya, 61511
mina raouf, 01015752424, drmina2015@gmail.com
About this study
Official title: Ultrasound Guided Sphenopalatine Ganglion Supravoltage Versus Standard Voltage Pulsed Radiofrequency for Pain Alleviation in Chronic Refractory Migraine. Randomized Double Blind Study
- PRF performed on the sphenopalatine ganglion level under ultrasound guidance.
- Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.
- Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage.
- Conditions
- Chronic Migraine, Headache
- Being tested
- Standarad PRF, Supravoltage PRF
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standarad PRFDevice
- Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.
Supravoltage PRFDevice
- Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage.
| Study group | Role | What they receive |
|---|---|---|
| standarad group | Active comparator | • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. Receives: Device: Standarad PRF |
| Supravoltage group | Active comparator | • Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage. Receives: Device: Supravoltage PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of population with ≥50% reduction in VAS score from pre-interventional values
VAS 1-3 MILD PAIN 4-5= MODERATE >6 SEVERE PAIN
A day is counted as a migraine day if:
Headache lasts ≥4 hours OR
Shorter but treated with migraine-specific medication (e.g., triptan)
Measured: 1 week, 1 month, 3,6 months POST INTERVENTIONAL
Secondary outcomes (3)
Proportion of participants achieving ≥50% reduction in monthly migraine days from baseline MMD is determined using a 4-week prospective headache diary prior.
A day is counted as a migraine day if:
Headache lasts ≥4 hours OR
Shorter but treated with migraine-specific medication (e.g., triptan)
Measured: 1,2,3,4,5,6 MONTHS POST INTERVENTIONAL
procedure related complications
Local: bleeding, hematoma, infection
Neurological: facial numbness, dysesthesia, neuralgia
Autonomic: lacrimation, nasal congestion
Auditory: tinnitus
Serious adverse events: intracranial injury, vascular injury
Measured: UP TO 6 months
NUMBER OF DAYS OF ACUTE MEDICATIONS USE REPORTED MONTHLY
A medication-use day was defined as any day on which at least one dose of acute migraine medication was taken, regardless of the number of doses."
Measured: 1,2,3,4,5,6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start31 Mar 2026
- Primary completion22 Mar 2027 (estimated)
- Study completion2 Apr 2027 (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.
- More trials run by Minia UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500558
- Sponsor's protocol ID
- R/740
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Sphenopalatine Ganglion Supravoltage Versus Standard Voltage Pulsed Radiofrequency for Pain Alleviation in Chronic Refractory Migraine. Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT07500558
- Acronym / sponsor ID
- R/740
- Conditions
- Chronic Migraine, Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 2 Apr 2027 (estimated)
- First posted
- 30 Mar 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.
- PRF performed on the sphenopalatine ganglion level under ultrasound guidance.
- Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.
- Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standarad group | Active comparator | Device: Standarad PRF• Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. |
| Supravoltage group | Active comparator | Device: Supravoltage PRF• Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of chronic migraine according to International Classification of Headache Disorders criteria (≥15 headache days/month for >3 months, including ≥8 migraine days/month) documented by Completion of 4-week prospective baseline headache diary immediately preceding randomization
Key exclusion criteria (11 listed)
- Medication Overuse Headache per ICHD-3: Simple analgesics (acetaminophen, NSAIDs, non-opioid analgesics) used on ≥15 days per month for >3 months, OR Triptans, ergot derivatives, opioids, or combination analgesics used on ≥10 days per month for >3 months.
- Any secondary headache disorder ( cluster headache, hemiplegic migraine, migraine with brainstem aura (distinct pathophysiology); chronic tension-type headache >10 days/month.
- Any prior SPG block, PRF, radiofrequency thermocoagulation, chemical neurolysis, or neurostimulation of SPG/trigeminal system within 6 month.
- No prior occipital or supra-orbital nerve radiofrequency, cryotherapy, or chemical neurolysis within 3 months
- Use of botulinum toxin (Botox) within 3 months or CGRP monoclonal antibodies within 3 months prior to enrollment.
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 |
|---|---|---|
| Standarad PRF• Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. | Device | standarad group |
| Supravoltage PRF• Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage. | Device | Supravoltage group |
Primary outcome
proportion of population with ≥50% reduction in VAS score from pre-interventional values
Time frame: 1 week, 1 month, 3,6 months POST INTERVENTIONAL
VAS 1-3 MILD PAIN 4-5= MODERATE >6 SEVERE PAIN A day is counted as a migraine day if: Headache lasts ≥4 hours OR Shorter but treated with migraine-specific medication (e.g., triptan)
3 secondary outcomes
Proportion of participants achieving ≥50% reduction in monthly migraine days from baseline MMD is determined using a 4-week prospective headache diary prior.
Time frame: 1,2,3,4,5,6 MONTHS POST INTERVENTIONAL
procedure related complications
Time frame: UP TO 6 months
NUMBER OF DAYS OF ACUTE MEDICATIONS USE REPORTED MONTHLY
Time frame: 1,2,3,4,5,6 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 16 Jun 2026.
Related trials for Chronic Migraine, Headache
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standarad PRF and Supravoltage PRF in people with Chronic Migraine, Headache, run by Minia University at 2 sites in Egypt.
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 6 inclusion and 11 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
proportion of population with ≥50% reduction in VAS score from pre-interventional values (time frame: 1 week, 1 month, 3,6 months POST INTERVENTIONAL). 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 16 Jun 2026.