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NCT Number: NCT06787677

SPG Pulsed Radiofrequency for Chronic Cluster Headache

Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.

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Key information

Conditions

Headache, Cluster Brain Diseases Central Nervous System Diseases Cluster Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fang Luo

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

59976661

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic cluster headache;
  • At least four attacks per week;
  • Minimum age of 18 years;
  • Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.

Exclusion criteria

  • Pregnancy or breastfeeding;
  • Presence of cardiac pacemaker or other neuromodulatory devices;
  • Pyschiatric and cognitive disorders;
  • Serious drug habituation or overuse of acute-headache medication;
  • History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;
  • Infection at the puncture site;
  • Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.

Treatment and study plan

PRF

Procedure

After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms.

NB

Procedure

After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine.

Primary outcomes

  1. The mean attack frequency in the last 4 weeks (week 8-12) after procedure

    Time frame: In the last 4 weeks (week 8-12) after procedure

    The overall mean change from baseline in mean weekly attack frequency

Secondary outcomes

  1. Mean attack frequency

    Time frame: From baseline to each 4-week interval through 1 year after procedure

    Mean change in mean attack frequency

  2. 50% reduction of mean attack frequency

    Time frame: From baseline to each 4-week interval through 1 year after procedure

    Percentage of patients with a 50% reduction in mean attack frequency

  3. 30% reduction of mean attack frequency

    Time frame: From baseline to each 4-week interval through 1 year after procedure

    Percentage of patients with a 30% reduction in mean attack frequency

  4. Patient Global Impression of Improvement

    Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure

    Percentage of patients reporting a score of 1 (''very much better'') or 2 (''much better'')

  5. Mean attack intensity

    Time frame: From baseline to each 4-week interval through 1 year after procedure

    0-10 on the numeric rating scale, with 0 equating no pain and 10 the worst pain possible

  6. Patient satisfaction scores

    Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure

    0 point indicates unsatisfied to 10 points indicate very satisfied. The higher the score, the more dissatisfied the patient is.

  7. The incidence of perioperative adverse events

    Time frame: Across 1 year after procedure

    Perioperative adverse events (AEs) including headache, dizziness, nausea, vomiting, facial hematoma, and numbness in the area innervated by the maxillary nerve

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

59976661

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jan 22, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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