NCT06917144

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Refractory Chronic Cluster Headache

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation	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.
DEVICE	Sham Stimulation	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.

Timeline

• Start date: 2023-12-21
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: Spain