Evaluating Repetitive Transcranial Magnetic Stimulation for Refractory Chronic Cluster Headache Prevention: Insights From a Randomised Crossover Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Reduction in number of attacks per week
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sequence A
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.
Intervention: Repetitive Transcranial Magnetic Stimulation (Device)
Sequence A
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.
Intervention: Sham Stimulation (Device)
Sequence B
Sequence B:
sham → washout → rTMS.
Intervention: Repetitive Transcranial Magnetic Stimulation (Device)
Sequence B
Sequence B:
sham → washout → rTMS.
Intervention: Sham Stimulation (Device)
Outcomes
Primary Outcomes
Reduction in number of attacks per week
Time Frame: 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 Outcomes
- 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 tolerability to treatment(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))
Investigators
Javier Díaz de Terán
PhD
Instituto de Investigación Hospital Universitario La Paz