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Headache, MigraineFRAIL-GONNCT07363083

Treatment Response to GON Pulsed Radiofrequency in Elderly Patients With Chronic Migraine

An observational study of Headache, Migraine, run by Ankara City Hospital Bilkent.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Headache disorders are highly prevalent in older adults, yet their management remains challenging due to comorbidities, polypharmacy, and the paucity of evidence derived from geriatric populations. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Headache, Migraine
How many people
100 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 1 May 2027
How long will I take part?
6 Months
Phase
Observational
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 65 years or over patients with chronical migraine

Who may be able to join

  • Age 65 years or older
  • Diagnosis of chronic migraine according to ICHD criteria
  • Presentation to the algology clinic
  • Eligibility for greater occipital nerve pulsed radiofrequency (GON-PRF) treatment according to the study protocol
  • Ability to provide written informed consent

Who cannot join

  • Acute headache or pain conditions
  • Malignancy-related headache
  • Severe cognitive or communication impairment

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ulku Sabunccu, Assoc. Prof. contact

+905337085212

sabuncuulku@gmail.com

About this study

Official title: Predictors of Treatment Response to Greater Occipital Nerve Pulsed Radiofrequency in Older Patients With Chronic Migraine

Headache disorders are highly prevalent in older adults, yet their management remains challenging due to comorbidities, polypharmacy, and the paucity of evidence derived from geriatric populations. Most randomized clinical trials exclude elderly patients, underscoring the need for effective and safe non-pharmacological treatment strategies for headache in this age group.

Greater occipital nerve blocks are commonly used in the treatment of migraine and other headache disorders; however, their clinical benefit is often transient. Pulsed radiofrequency (PRF) has been introduced as a minimally invasive technique aimed at prolonging therapeutic effects through neuromodulation without causing structural neural damage. Although greater occipital nerve pulsed radiofrequency (GON-PRF) has demonstrated efficacy in various headache disorders, its effectiveness in patients aged 65 years and older has not been adequately investigated.

The primary aim of this study is to evaluate the effectiveness of GON-PRF in patients aged ≥65 years with chronic migraine by assessing changes in pain intensity, monthly headache days, and monthly severe headache days. The secondary aim is to identify geriatric predictors of treatment response, including frailty status and the Geriatric Nutritional Risk Index (GNRI), in order to support individualized treatment strategies for older adults.

Read the detailed description

Headache disorders are common across all age groups. As the global population ages, the number of older adults affected by headache disorders continues to rise, and an increasing proportion of elderly individuals seek medical care for headache-related complaints. Although primary headache disorders remain prevalent in this population, secondary causes must always be excluded as a first step. Previous estimates suggest that the one-year prevalence of primary headache disorders in adults aged 55-94 years is approximately 40.5% (1).

The management of headache in geriatric patients is often complex and challenging, requiring careful consideration of multiple factors, including comorbidities, polypharmacy, potential drug interactions, and age-related adverse effects. Moreover, evidence guiding headache treatment in older adults is limited, as most published clinical trials have excluded elderly populations. Consequently, there is a clear need for effective treatment options for headache in older adults, particularly non-pharmacological approaches that are less influenced by comorbid conditions and medication burden.

Peripheral nerve blocks, particularly greater occipital nerve blocks (GONB), have long been used in the treatment of various headache disorders and cranial neuralgias, including migraine, cluster headache, and cervicogenic headache, and may represent a safe alternative to standard pharmacotherapy in this demographic. In a retrospective study by Hascalovici et al., which evaluated the demographic, clinical, and therapeutic characteristics of patients aged 65 years and older treated with peripheral nerve blocks (greater and/or lesser occipital, auriculotemporal, supraorbital, and supratrochlear nerves), peripheral nerve blocks were reported to be a safe and effective headache management strategy for older adults (2).

Although greater occipital nerve blocks performed with local anesthetics and/or corticosteroids have demonstrated clinical benefit in the treatment of headache disorders, the duration of their efficacy is often limited. Pulsed radiofrequency (PRF) therapy has been introduced as a minimally invasive technique to prolong therapeutic effects. PRF modulates pain transmission by generating an electric field at the targeted nerve without causing structural damage to neural tissue or surrounding structures (3). A recent systematic review evaluating the efficacy and safety of greater occipital nerve pulsed radiofrequency in headache disorders reported that GON-PRF was effective in reducing pain intensity and headache frequency across various primary headache conditions, with a favorable safety profile.

Keywords
Migraine Headache, Elderly, Frail, Nerve Blockade
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07363083
Study groupRoleWhat they receive
GON_PRF groupThis study is a single-center, prospective, single-arm interventional clinical trial designed to evaluate the effectiveness of greater occipital nerve pulsed radiofrequency (GON-PRF) treatment and to identify predictors of treatment response in patients aged 65 years and older with a diagnosis of chronic migraine. Within the scope of the study, patients presenting to the algology clinic who meet the inclusion criteria will undergo ultrasound-guided GON-PRF treatment in accordance with standard clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome

    VAS: Pain intensity, assessed by the Visual Analog Scale

    Measured: baseline, 1st month, 3rd month

  2. Primary outcme

    Monthly headache frequency

    Measured: baseline, 1st month, 3rd month

  3. Primary outcome

    Number of headache days per month

    Measured: baseline, 1st month, 3rd month.

Secondary outcomes (2)
  1. secondary outcome

    Baseline frailty index

    Measured: baseline

  2. secondary outcome

    Baseline nutritional index (GNRI)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363083
Sponsor's protocol ID
111213
Acronym
FRAIL-GON
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Park D, Chang MC. The mechanism of action of pulsed radiofrequency in reducing pain: a narrative review. J Yeungnam Med Sci. 2022 Jul;39(3):200-205. doi: 10.12701/jyms.2022.00101. Epub 2022 Apr 7.

    PubMed 35385898

Questions about this trial

What is this clinical trial studying?

An observational study of Headache, Migraine, run by Ankara City Hospital Bilkent.

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 5 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Ulku Sabunccu, Assoc. Prof. (+905337085212, sabuncuulku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome (time frame: baseline, 1st month, 3rd month). The study lists 3 primary outcomes in all. 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 NCT07363083, which also lists 1 linked publication.

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 10 Feb 2026.

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