Refractory Chronic Cluster HeadacheNCT06917144
Refractory Chronic Cluster Headache: Exploring the Potential of Repetitive Transcranial Magnetic Stimulation
A study testing Repetitive Transcranial Magnetic Stimulation in people with Refractory Chronic Cluster Headache, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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 ?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Chronic Cluster Headache
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Repetitive Transcranial Magnetic Stimulation for Refractory Chronic Cluster Headache Prevention: Insights From a Randomised Crossover Pilot Trial
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 ?
Read more
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
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Stimulation
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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.
Sham StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Stimulation |
| Sequence B | Other | Sequence B:
sham → washout → rTMS. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: 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
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).
Measured: 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
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).
Measured: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
To assess the tolerability to treatment
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).
Measured: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start21 Dec 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory Chronic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Díaz de Terán, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917144
- Sponsor's protocol ID
- PI-6581
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40563725
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Repetitive Transcranial Magnetic Stimulation for Refractory Chronic Cluster Headache Prevention: Insights From a Randomised Crossover Pilot Trial
- ClinicalTrials.gov ID
- NCT06917144
- Acronym / sponsor ID
- PI-6581
- Conditions
- Refractory Chronic Cluster Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Device: Repetitive Transcranial Magnetic Stimulation, Device: Sham StimulationThe 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. |
| Sequence B | Other | Device: Repetitive Transcranial Magnetic Stimulation, Device: Sham StimulationSequence B: sham → washout → rTMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationStimulation 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 | Sequence A, Sequence B |
| Sham StimulationSham 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. | Device | Sequence A, Sequence B |
Primary outcome
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).
4 secondary outcomes
Assessing the reduction in symptomatic medication use.
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
To assess the tolerability to treatment
Time frame: From enrollment to the end of follow up period, at 3 months after second treatment period (week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 40563725Portocarrero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Refractory Chronic Cluster Headache, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.