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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | 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. |
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| Sequence B | Other | Sequence B: sham → washout → rTMS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end to follow up period, at 3 months after last treatment period (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40563725 | Derived | Portocarrero-Sanchez L, Rizea C, Diez-Tejedor E, Leon-Ruiz M, Diaz-de-Teran J. Evaluating Repetitive Transcranial Magnetic Stimulation for Refractory Chronic Cluster Headache Prevention: Insights from a Randomized Crossover Pilot Trial. Brain Sci. 2025 May 23;15(6):554. doi: 10.3390/brainsci15060554. |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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. |
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| 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). | 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). | 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). | From enrollment to the end of follow up period, at 3 months after second treatment period (week 8) |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |