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

Madrid Health Service

Status: Completed

Conditions: Refractory Chronic Cluster Headache

Treatments: Device: Sham Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06917144

PI-6581

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Sequence A

Other group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Device: Sham Stimulation

Sequence B

Other group

Description:

Sequence B: sham → washout → rTMS.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Device: Sham Stimulation