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

NCT06917144 | Completed

• 1 other identifier: PI-6581
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Refractory Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• To assess the tolerability to treatment

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

Study Arms (2)

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.

Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Stimulation

Sequence B

OTHER

Sequence B: sham → washout → rTMS.

Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Stimulation

Interventions

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.

Sequence A; Sequence B

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.

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 40563725 DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 8, 2025
• Study Start: December 21, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)