ClinicalTrials.gg
RecruitingNCT07500558Updated Jun 16, 2026

Ultrasound Guided Infratemporal Sphenopalatine Ganglion Supravoltage Versus Standard Voltage Pulsed Radiofrequency for Pain Alleviation in Chronic Refractory Migraine.

An interventional study of Standarad PRF and Supravoltage PRF in Chronic Migraine, Headache, sponsored by Minia University. Recruiting at 2 sites in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.
  • 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.
02

Conditions studied

  • Chronic Migraine, Headache

Browse trials for

03

In context

Headache

762 studies on the registry are indexed under Headache; 134 are open to participants now.

This study's planned enrollment of 100 is above the median of 65 across 560 interventional studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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 . Positive response (≥50% pain reduction within 30-60 minutes) to diagnostic INFRATEMPORAL sphenopalatine ganglion block using 2% lidocaine (2 mL) infrazygomatic approach

Exclusion criteria

Exclusion Criteria:

  • 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 ( criteria) within 12 months; PHQ-9 ≥20 or cognitive impairment affecting reporting reliability.
  • 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 therapy within 3 months prior to enrollment.

Coagulopathy ( \<100,000 or >1.5) or ongoing anticoagulation not safely withheld.

-Patient refusal.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    standarad group

    • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.

    Device: Standarad PRF

  • Active comparator
    Supravoltage group

    • 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 PRF

Interventions

  • DeviceStandarad PRF

    • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.

  • DeviceSupravoltage 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 week, 1 month, 3,6 months POST INTERVENTIONAL

Secondary outcomes

  1. 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)

    Time frame: 1,2,3,4,5,6 MONTHS POST INTERVENTIONAL

  2. 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

    Time frame: UP TO 6 months

  3. 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."

    Time frame: 1,2,3,4,5,6 MONTHS

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.

Of 175 non-industry interventional studies with no phase under Headache, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 11 months is below that.

Counting every sponsor, half of 193 studies reached it within 14 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2026
First posted
Mar 30, 2026
StartActual
Mar 31, 2026
Primary completionEst.
Mar 22, 2027
CompletionEst.
Apr 2, 2027
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07500558
Lead sponsor
Minia University
Responsible party
Mina Maher (Ass professor anesthesia and pain, Minia University) — Principal investigator
First posted
Mar 30, 2026
Start date
Mar 31, 2026
Primary completion
Mar 22, 2027 (estimated)
Completion
Apr 2, 2027 (estimated)
Last update
Jun 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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