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Completed

NCT Number: NCT06917144

Refractory Chronic Cluster Headache: Exploring the Potential of Repetitive Transcranial Magnetic Stimulation

The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are:

Does Transcranial Magnetic Stimulation lower the number of attacks per week in patients with refractory cluster headache ?

Researchers will compare transcranial magnetic stimlation to a sham stimulation (a look-alike stimulation) to see if it works to prevent attacks of cluster headache.

Participants will:

Recieve stimulation for 10 minutes for 10 consecutive working days in 2 periods of time, separated by a 1 month washout period.

Visit the clinic for each treatment day. Keep a diary of their symptoms and the number of times they use a rescue medication

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Key information

Conditions

Refractory Chronic Cluster Headache 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

Hospital Universitario La Paz

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Diagnosed with Chronic Cluster Headache (CCH) based on the International Classification of Headache Disorders 3rd Edition
  • Diagnosed with refractory CCH based on the European Headache Federation criteria of 2014.

Exclusion criteria

  • History of epilepsy.
  • Concomitant diagnosis of any other headache (if the patient was unable to differentiate between them).
  • Carriers of any electronic device, or any additional contraindication for Transcranial Magnetic Stimulation, such as pregnancy.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Stimulation sessions were performed using a YINGCHI M-100 Ultimate device with liquid-cooled figure-8 coils.

Patients attended 10-minute sessions daily for 10 consecutive working days. For rTMS, stimulation was delivered at an excitatory frequency of 10 Hz, targeting the M1, contralateral to the side of pain in the facial region.

Each session consisted of the following steps.

  • 10 series: 60 pulses per series (600 pulses in total).
  • Rest intervals: 60 seconds between series.
  • Intensity: 70% of the resting motor threshold (RMT). RMT was determined using single-pulse stimulation over the M1 region controlling the abductor pollicis brevis muscle, localized via neuronavigation. The threshold was de-fined as the lowest stimulator intensity producing a motor-evoked potential amplitude >50 µV in at least 5 of 10 trials.

Sham stimulation

Device

Sham Stimulation:

The same device and protocol used for intervention protocol with Repetitive Transcranial Magnetic Stimulation were used for sham stimulation, but no active stimulation was delivered. The equipment produced identical sounds and appearances, thereby ensuring blinding.

Primary outcomes

  1. Reduction in number of attacks per week

    Time frame: From enrollment to the end to follow up period, at 3 months after last treatment period (week 8)

    The mean change in the number of attacks per week at the end of each treatment period was compared with the baseline, from the time of informed consent until the last follow-up moment (3 months after the end of the second treatment period).

Secondary outcomes

  1. Assessing the reduction in symptomatic medication use.

    Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)

    The use of symptomatic medication was assessed through electronic questionnaires completed by the patient.

    The mean change in the use of symptomatic medication at the end of each treatment period was compared with the baseline, from the time of informed consent until the last follow-up moment (3 months after the end of the second treatment period).

  2. To assess the reduction in intensity of cluster headache attacks

    Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)

    The intensity of the attacks of cluster headache was assessed through electronic questionnaires completed by the patient, using the visual analogue scale from 1 to 10.

    The mean change in the intensity at the end of each treatment period was compared with the baseline, from the time of informed consent until the last follow-up moment (3 months after the end of the second treatment period).

  3. To assess the change in duration in cluster headache attacks

    Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)

    The duration of the attacks of cluster headache was assessed through electronic questionnaires completed by the patient (minutes). The mean change in the duration at the end of each treatment period was compared with the baseline, from the time of informed consent until the last follow-up moment (3 months after the end of the second treatment period).

  4. To assess the tolerability to treatment

    Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)

    The tolerability to treatment was assessed through electronic questionnaires completed by the patient, reporting any symptom experienced during treatment. It was then evaluated its possible relationship to rTMS. The adverse effects were evaluated from the time of informed consent until the last follow-up moment (3 months after the end of the second treatment period).

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

Evaluating Repetitive Transcranial Magnetic Stimulation for Refractory Chronic Cluster Headache Prevention: Insights From a Randomised Crossover Pilot Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2025
Registry last updated
Apr 8, 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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