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

NCT06917144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917144 on ClinicalTrials.gov