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

Not Applicable

Completed

• Conditions: Refractory Chronic Cluster Headache

• Registration Number: NCT06917144
• Lead Sponsor: Hospital Universitario La Paz

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reduction in number of attacks per week	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 Outcome Measures

Name	Time	Method
Assessing the reduction in symptomatic medication use.	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).
To assess the reduction in intensity of cluster headache attacks	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).
To assess the tolerability to treatment	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).
To assess the change in duration in cluster headache attacks	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).

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain