An interventional study of Repetitive Transcranial Magnetic Stimulation and Sham Stimulation in Refractory Chronic Cluster Headache, sponsored by Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Hospital Universitario La Paz · Not applicable, Interventional, and Prevention
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
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 8 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Hospital Universitario La Paz is the lead sponsor of 56 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study consisted of two treatment periods (rTMS and sham stimulation), separated by a one-month washout period, and organized into two sequences (A and B) Sequence A: rTMS → washout → sham. Sequence B: sham → washout → rTMS.
Device: Repetitive Transcranial Magnetic Stimulation · Device: Sham Stimulation
Sequence B: sham → washout → rTMS.
Device: Repetitive Transcranial Magnetic Stimulation · Device: Sham 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.
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.
Reduction in number of attacks per week
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).
Time frame: From enrollment to the end to follow up period, at 3 months after last treatment period (week 8)
Assessing the reduction in symptomatic medication use.
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).
Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
To assess the reduction in intensity of cluster headache attacks
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).
Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
To assess the change in duration in cluster headache attacks
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).
Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
To assess the tolerability to treatment
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).
Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
Plan to share: No
Ran from Dec 2023 to primary completion in May 2024, 5 months.
Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Paz