Cluster HeadacheNCT06206772
Resting State Functional Connectivity in Cluster Headache
An observational study of Cluster Headache and Headache Disorders, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial summary
Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cluster Headache, Headache Disorders
- What is being tested?
- Resting state HD-EEG recording
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to Feb 2025
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with episodic and chronic cluster headache patients attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
Who may be able to join
- Diagnosis of 3.1.1 episodic cluster headache, or 3.1.2 chronic cluster headache, according to the International Classification of Headache Disorders-3 (ICHD-3) criteria
- History of at least 1 year of disease
- For the active-phase recording (T0) in eCH, no preventive medication ongoing or verapamil at a stable dose for at least 2 weeks
- For the remission-phase recording (T1), no preventive medication ongoing, and at least 14 headache-free days since preventive discontinuation
- Age and sex-matched healthy volunteers, without history of headache disorders except sporadic tension-type headache according to ICHD-3 criteria
Who cannot join
- Previous or actual history of epilepsy
- Diagnosis of dementia o mental retardation
- Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- Other concomitant type of headache (except for sporadic tension type headache)
- Chronic pain conditions
- Pregnancy or breastfeeding
Show all 21Show fewer
- Concomitant use of electrical stimulators, pace-makers, metallic clips or other metallic foreign bodies
- Previous head surgery
- Ongoing neuroactive prevention therapies or other drugs, or psychoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- Other conditions possibly influencing EEG recording
- Brain anomalies detected on MRI
- Healthy controls (HCs)
- Previous or actual history of epilepsy
- Diagnosis of dementia o mental retardation
- Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- Chronic pain conditions
- Pregnancy or breastfeeding
- Concomitant use of electrical stimulators, pace-makers, metallic clips or other metallic foreign bodies
- Previous head surgery
- Ongoing neuroactive prevention therapies or other drugs, or psychoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- Other conditions possibly influencing EEG recording
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Headache Science & Neurorehabilitation Center
Pavia, 27100
Roberto De Icco, Prof, 00382380425, roberto.deicco@mondino.it
About this study
Official title: The Role of Resting State Networks Connectivity in Cluster Headache: a HD-EEG Study
Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Notably, the mechanisms underlying the shift between the remission phase and cluster bout are poorly understood.
Thus, the investigators aim to study brain connectivity in episodic cluster headache patients. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
Read the detailed description
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity. High density EEG (HD-EEG), enables to record electrical brain activity with high temporal and spatial resolution. Through the analysis of brain oscillations across different frequency bands (from alpha to delta), it can evaluate sensory, pain processing and information integration, thus detecting potential markers or predictors for therapeutic interventions.
Previous neurophysiological studies focused on EEG and to assess functional connectivity or spectral analysis in migraine patients, with no data in cluster headache. Conventional studies found higher slow wave activity (predominantly theta) in the inter-ictal phase and higher excitability in the visual cortex during visual aura.
In 2016 a resting state study showed a predominance of low frequency bands in the ictal phase. The interictal and ictal phases patients also presented a diffuse lower coherence, suggesting low functional connectivity. Furthermore, an altered spatial connectivity for lower alpha-band activities was found in the interictal phases during sensory stimulation by means of HD-EEG, suggesting a thalamocortical dysrhythmia.
The primary aim of the study is to evaluate changes in functional connectivity in episodic cluster headache patients, comparing the active phase with the remission phase. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
Study design:
Episodic cluster headache patients (eCH) will be evaluated in two separate timepoints: during the active phase (T0), defined as at least one week of active bout, and in remission phase (T1), defined as at leat 14 days without headache and without any ongoing preventive medication. During each visit, clinical data will be collected, and an HD-EEG will be performed.
Chronic cluster headache patients (cCH) will be evaluated in a single timepoint, and healthy controls will undergo HD-EEG registration once.
HD-EEG registration:
Participants will perform 4 recordings (6 minutes each) in resting-state condition, 2 with opened eyes, and 2 with closed eyes, in a randomized order.
The investigators will analyze the resting state FC among six resting state networks (Default mode network, Dorsal attention network, Ventral attention network, Language network , Somatomotor network and Visual network) in the following frequency bands: alfa 8-12 Hz, beta 13-30 Hz, gamma 31-80 Hz, theta 4-7 Hz. delta 1-3 Hz.
Acquisition parameters will be: High-Pass: 0.5 Hz; Low-Pass: 100 Hz; Notch: 50 Hz. For analysis of HD-EEG data, a tailored analysis pipe-line that was previously developed and validated to reconstruct neural sources from cortical/subcortical gray matter will be performed. EEG signals will be band-pass filtered (1-80 Hz) and down-sampled at 250 Hz. Biological artifacts will be rejected using Independent Component Analysis (ICA). EEG signals will be referenced with a customized version of the Reference Electrode Standardization Technique (REST). A matrix will estimate the relationship between the measured scalp potentials and the dipoles corresponding to brain sources. Sources reconstruction will be performed with the exact low-resolution brain electromagnetic tomography (eLORETA) algorithm
Statistical plan:
The sample size was computed with the freeware online platform www.openepi.com. As there are no previous studies on HD-EEG functional connectivity in cluster headache, our sample size analysis was based on the work of Bjork (Bjork et al., 2009). A difference between groups in the theta relative power band equal to 0.04 (±0.04) will be considered as clinically meaningful. Considering a two-tailed t-test for the comparison with confidence interval 95%; power: 80%, the minimum suggested sample size was 20 subjects for group.
A preliminary normality analysis will be performed to decide whether to use parametric or non-parametric methods, through Shapiro Wilk test.
Numerical variables will be described as mean and standard deviation (or median and quartiles if appropriate), categorical variables as raw numbers and percentages.
Functional connectivity analyses will be conducted for separate bands and eyes closed registration.
- Conditions
- Cluster Headache, Headache Disorders
- Being tested
- Resting state HD-EEG recording
- Medical subject headings
- Cluster Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting state HD-EEG recordingDiagnostic test
All subjects will be recorded with a resting state HD-EEG recording. 12 minutes in the eyes closed and 12 minutes in the eyes open condition.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Diagnostic Test: Resting state HD-EEG recording | |
| Episodic cluster headache, active | Not described Receives: Diagnostic Test: Resting state HD-EEG recording | |
| Episodic cluster headache, remission | Not described Receives: Diagnostic Test: Resting state HD-EEG recording | |
| Chronic cluster headache | Not described Receives: Diagnostic Test: Resting state HD-EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in episodic cluster headache patients between active and remission phases
To compare HD-EEG functional connectivity in episodic cluster headache patients between the two phases of the disease
Measured: Through study completion, an average of 2 years
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and healthy controls
To compare HD-EEG functional connectivity between episodic cluster headache patients in the two phases of the disease and healthy controls
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and chronic cluster headache patients
To compare HD-EEG functional connectivity between episodic cluster headache patients and chronic cluster headache patients
Measured: Through study completion, an average of 1 year
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between chronic cluster headache patients and healthy controls
To compare HD-EEG functional connectivity between chronic cluster headache patients and healthy controls
Measured: Single evaluation in chronic cluster headache (cCH) vs. healthy controls (HCs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto De Icco, MD, Principal investigator, Headache Science ahd Neurorehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206772
- Sponsor's protocol ID
- HD-EEG in Cluster Headache
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Bjork MH, Stovner LJ, Engstrom M, Stjern M, Hagen K, Sand T. Interictal quantitative EEG in migraine: a blinded controlled study. J Headache Pain. 2009 Oct;10(5):331-9. doi: 10.1007/s10194-009-0140-4. Epub 2009 Aug 25.
PubMed 19705061Coppola G, Di Lorenzo C, Parisi V, Lisicki M, Serrao M, Pierelli F. Clinical neurophysiology of migraine with aura. J Headache Pain. 2019 Apr 29;20(1):42. doi: 10.1186/s10194-019-0997-9.
PubMed 31035929de Tommaso M, Trotta G, Vecchio E, Ricci K, Siugzdaite R, Stramaglia S. Brain networking analysis in migraine with and without aura. J Headache Pain. 2017 Sep 29;18(1):98. doi: 10.1186/s10194-017-0803-5.
PubMed 28963615Cao Z, Lin CT, Chuang CH, Lai KL, Yang AC, Fuh JL, Wang SJ. Resting-state EEG power and coherence vary between migraine phases. J Headache Pain. 2016 Dec;17(1):102. doi: 10.1186/s10194-016-0697-7. Epub 2016 Nov 2.
PubMed 27807767Chamanzar A, Haigh SM, Grover P, Behrmann M. Abnormalities in cortical pattern of coherence in migraine detected using ultra high-density EEG. Brain Commun. 2021 Apr 2;3(2):fcab061. doi: 10.1093/braincomms/fcab061. eCollection 2021.
PubMed 34258580Semprini M, Bonassi G, Barban F, Pelosin E, Iandolo R, Chiappalone M, Mantini D, Avanzino L. Modulation of neural oscillations during working memory update, maintenance, and readout: An hdEEG study. Hum Brain Mapp. 2021 Mar;42(4):1153-1166. doi: 10.1002/hbm.25283. Epub 2020 Nov 17.
PubMed 33200500Aoki Y, Ishii R, Pascual-Marqui RD, Canuet L, Ikeda S, Hata M, Imajo K, Matsuzaki H, Musha T, Asada T, Iwase M, Takeda M. Detection of EEG-resting state independent networks by eLORETA-ICA method. Front Hum Neurosci. 2015 Feb 10;9:31. doi: 10.3389/fnhum.2015.00031. eCollection 2015.
PubMed 25713521
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Resting State Networks Connectivity in Cluster Headache: a HD-EEG Study
- ClinicalTrials.gov ID
- NCT06206772
- Acronym / sponsor ID
- HD-EEG in Cluster Headache
- Conditions
- Cluster Headache, Headache Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 16 Jan 2024 (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.
Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Notably, the mechanisms underlying the shift between the remission phase and cluster bout are poorly understood.
Thus, the investigators aim to study brain connectivity in episodic cluster headache patients. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
Detailed description
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity. High density EEG (HD-EEG), enables to record electrical brain activity with high temporal and spatial resolution. Through the analysis of brain oscillations across different frequency bands (from alpha to delta), it can evaluate sensory, pain processing and information integration, thus detecting potential markers or predictors for therapeutic interventions.
Previous neurophysiological studies focused on EEG and to assess functional connectivity or spectral analysis in migraine patients, with no data in cluster headache. Conventional studies found higher slow wave activity (predominantly theta) in the inter-ictal phase and higher excitability in the visual cortex during visual aura.
In 2016 a resting state study showed a predominance of low frequency bands in the ictal phase. The interictal and ictal phases patients also presented a diffuse lower coherence, suggesting low functional connectivity. Furthermore, an altered spatial connectivity for lower alpha-band activities was found in the interictal phases during sensory stimulation by means of HD-EEG, suggesting a thalamocortical dysrhythmia.
The primary aim of the study is to evaluate changes in functional connectivity in episodic cluster headache patients, comparing the active phase with the remission phase. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
Study design:
Episodic cluster headache patients (eCH) will be evaluated in two separate timepoints: during the active phase (T0), defined as at least one week of active bout, and in remission phase (T1), defined as at leat 14 days without headache and without any ongoing preventive medication. During each visit, clinical data will be collected, and an HD-EEG will be performed.
Chronic cluster headache patients (cCH) will be evaluated in a single timepoint, and healthy controls will undergo HD-EEG registration once.
HD-EEG registration:
Participants will perform 4 recordings (6 minutes each) in resting-state condition, 2 with opened eyes, and 2 with closed eyes, in a randomized order.
The investigators will analyze the resting state FC among six resting state networks (Default mode network, Dorsal attention network, Ventral attention network, Language network , Somatomotor network and Visual network) in the following frequency bands: alfa 8-12 Hz, beta 13-30 Hz, gamma 31-80 Hz, theta 4-7 Hz. delta 1-3 Hz.
Acquisition parameters will be: High-Pass: 0.5 Hz; Low-Pass: 100 Hz; Notch: 50 Hz. For analysis of HD-EEG data, a tailored analysis pipe-line that was previously developed and validated to reconstruct neural sources from cortical/subcortical gray matter will be performed. EEG signals will be band-pass filtered (1-80 Hz) and down-sampled at 250 Hz. Biological artifacts will be rejected using Independent Component Analysis (ICA). EEG signals will be referenced with a customized version of the Reference Electrode Standardization Technique (REST). A matrix will estimate the relationship between the measured scalp potentials and the dipoles corresponding to brain sources. Sources reconstruction will be performed with the exact low-resolution brain electromagnetic tomography (eLORETA) algorithm
Statistical plan:
The sample size was computed with the freeware online platform www.openepi.com. As there are no previous studies on HD-EEG functional connectivity in cluster headache, our sample size analysis was based on the work of Bjork (Bjork et al., 2009). A difference between groups in the theta relative power band equal to 0.04 (±0.04) will be considered as clinically meaningful. Considering a two-tailed t-test for the comparison with confidence interval 95%; power: 80%, the minimum suggested sample size was 20 subjects for group.
A preliminary normality analysis will be performed to decide whether to use parametric or non-parametric methods, through Shapiro Wilk test.
Numerical variables will be described as mean and standard deviation (or median and quartiles if appropriate), categorical variables as raw numbers and percentages.
Functional connectivity analyses will be conducted for separate bands and eyes closed registration.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Diagnostic Test: Resting state HD-EEG recording |
| Episodic cluster headache, active | – | Diagnostic Test: Resting state HD-EEG recording |
| Episodic cluster headache, remission | – | Diagnostic Test: Resting state HD-EEG recording |
| Chronic cluster headache | – | Diagnostic Test: Resting state HD-EEG recording |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with episodic and chronic cluster headache patients attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
Key inclusion criteria (5 listed)
- Diagnosis of 3.1.1 episodic cluster headache, or 3.1.2 chronic cluster headache, according to the International Classification of Headache Disorders-3 (ICHD-3) criteria
- History of at least 1 year of disease
- For the active-phase recording (T0) in eCH, no preventive medication ongoing or verapamil at a stable dose for at least 2 weeks
- For the remission-phase recording (T1), no preventive medication ongoing, and at least 14 headache-free days since preventive discontinuation
- Age and sex-matched healthy volunteers, without history of headache disorders except sporadic tension-type headache according to ICHD-3 criteria
Key exclusion criteria (21 listed)
- Previous or actual history of epilepsy
- Diagnosis of dementia o mental retardation
- Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- Other concomitant type of headache (except for sporadic tension type headache)
- Chronic pain conditions
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 |
|---|---|---|
| Resting state HD-EEG recordingAll subjects will be recorded with a resting state HD-EEG recording. 12 minutes in the eyes closed and 12 minutes in the eyes open condition. | Diagnostic test | Chronic cluster headache, Episodic cluster headache, active, Episodic cluster headache, remission, Healthy subjects |
Primary outcome
Difference in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in episodic cluster headache patients between active and remission phases
Time frame: Through study completion, an average of 2 years
To compare HD-EEG functional connectivity in episodic cluster headache patients between the two phases of the disease
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and healthy controls
Time frame: Through study completion, an average of 2 years
To compare HD-EEG functional connectivity between episodic cluster headache patients in the two phases of the disease and healthy controls
2 secondary outcomes
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and chronic cluster headache patients
Time frame: Through study completion, an average of 1 year
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between chronic cluster headache patients and healthy controls
Time frame: Single evaluation in chronic cluster headache (cCH) vs. healthy controls (HCs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 19705061Bjork MH, Stovner LJ, Engstrom M, Stjern M, Hagen K, Sand T. Interictal quantitative EEG in migraine: a blinded controlled study. J Headache Pain. 2009 Oct;10(5):331-9. doi: 10.1007/s10194-009-0140-4. Epub 2009 Aug 25.
- Background: PubMed 31035929Coppola G, Di Lorenzo C, Parisi V, Lisicki M, Serrao M, Pierelli F. Clinical neurophysiology of migraine with aura. J Headache Pain. 2019 Apr 29;20(1):42. doi: 10.1186/s10194-019-0997-9.
- Background: PubMed 28963615de Tommaso M, Trotta G, Vecchio E, Ricci K, Siugzdaite R, Stramaglia S. Brain networking analysis in migraine with and without aura. J Headache Pain. 2017 Sep 29;18(1):98. doi: 10.1186/s10194-017-0803-5.
- Background: PubMed 27807767Cao Z, Lin CT, Chuang CH, Lai KL, Yang AC, Fuh JL, Wang SJ. Resting-state EEG power and coherence vary between migraine phases. J Headache Pain. 2016 Dec;17(1):102. doi: 10.1186/s10194-016-0697-7. Epub 2016 Nov 2.
- Background: PubMed 34258580Chamanzar A, Haigh SM, Grover P, Behrmann M. Abnormalities in cortical pattern of coherence in migraine detected using ultra high-density EEG. Brain Commun. 2021 Apr 2;3(2):fcab061. doi: 10.1093/braincomms/fcab061. eCollection 2021.
- Background: PubMed 33200500Semprini M, Bonassi G, Barban F, Pelosin E, Iandolo R, Chiappalone M, Mantini D, Avanzino L. Modulation of neural oscillations during working memory update, maintenance, and readout: An hdEEG study. Hum Brain Mapp. 2021 Mar;42(4):1153-1166. doi: 10.1002/hbm.25283. Epub 2020 Nov 17.
- Background: PubMed 25713521Aoki Y, Ishii R, Pascual-Marqui RD, Canuet L, Ikeda S, Hata M, Imajo K, Matsuzaki H, Musha T, Asada T, Iwase M, Takeda M. Detection of EEG-resting state independent networks by eLORETA-ICA method. Front Hum Neurosci. 2015 Feb 10;9:31. doi: 10.3389/fnhum.2015.00031. eCollection 2015.
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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.
Roberto De Icco, MD principal investigator
Headache Science ahd Neurorehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache and Headache Disorders, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cinzia Fattore, MD (0382380385 ext. 0039, cinzia.fattore@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in episodic cluster headache patients between active and remission phases (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 NCT06206772, which also lists 8 linked publications.
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 16 Jan 2024.