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
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.
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- 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.
- 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