Cluster HeadacheCHADNCT02640105
Cluster Headache, Addictions and Vascular Function
An observational study of Cluster Headache, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Neurological clinical examination, Psychological clinical examination and Questionnaires
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2014to 10 Jun 2016
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with cluster headache
Who may be able to join
- Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) criteria, in active or inactive phase.
Who cannot join
- Other primary headaches
- Subjects without social insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Headache (CH), Addictions and Vascular Function
Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.
Read the detailed description
Several studies have shown an association between Cluster headache (CH) and smoking. However, no data exists on the link between CH and other addictions, and impact of these addictions on clinical characteristics of the disease. In addition, despite the strong biological link between CH and the vascular system, systematic investigations about vascular functions in CH patients are lacking.
This will be a prospective cohort study of 150 patients with CH, conducted in the Headache Center in Bordeaux, France.
- Conditions
- Cluster Headache
- Being tested
- Neurological clinical examination, Psychological clinical examination, Questionnaires, Blood sample, Endothelial function measurement
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological clinical examinationOther
Diagnostic and description of cluster headache
Psychological clinical examinationOther
Scale and questionnaires
QuestionnairesOther
Psychopathological and cognitive questionnaires
Blood sampleOther
Blood sample for DNA collection
Endothelial function measurementOther
Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device
| Study group | Role | What they receive |
|---|---|---|
| Patient with Cluster headache | Prospective follow-up of patient with Cluster headache Receives: Other: Neurological clinical examination; Other: Psychological clinical examination; Other: Questionnaires; Other: Blood sample; Other: Endothelial function measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of active periods of cluster headache
Measured: Day 0 (Inclusion visit)
Number of active periods
Measured: Day 0 (Inclusion visit)
Duration of cluster headache
Measured: Day 0 (Inclusion visit)
Severity of attacks
Measured: Day 0 (Inclusion visit)
Duration of active periods of cluster headache
Measured: one year after inclusion
Number of active periods
Measured: one year after inclusion
Duration of cluster headache
Measured: one year after inclusion
Severity of attacks
Measured: one year after inclusion
Secondary outcomes (5)
Existence of an addiction
Measured: Day 0 (Inclusion visit)
Existence of an addiction
Measured: One year after inclusion
Severity of Addiction
Measured: Day 0 (Inclusion visit)
Severity of Addiction
Measured: One year after inclusion
Reactive Hyperemic Index (RHI)
Endothelial function measurement
Measured: Day 0 (Inclusion visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study start25 Jun 2014
- Primary completion10 Jun 2016
- Study completion10 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640105
- Sponsor's protocol ID
- CHUBX 2013/14
- Acronym
- CHAD
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Headache (CH), Addictions and Vascular Function
- ClinicalTrials.gov ID
- NCT02640105
- Acronym / sponsor ID
- CHAD / CHUBX 2013/14
- Conditions
- Cluster Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 28 Dec 2015 (estimated)
- 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 (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.
Detailed description
Several studies have shown an association between Cluster headache (CH) and smoking. However, no data exists on the link between CH and other addictions, and impact of these addictions on clinical characteristics of the disease. In addition, despite the strong biological link between CH and the vascular system, systematic investigations about vascular functions in CH patients are lacking.
This will be a prospective cohort study of 150 patients with CH, conducted in the Headache Center in Bordeaux, France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Cluster headache | – | Other: Neurological clinical examination, Other: Psychological clinical examination, Other: Questionnaires, Other: Blood sample, Other: Endothelial function measurementProspective follow-up of patient with Cluster headache |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cluster headache
Key inclusion criteria (1 listed)
- Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) criteria, in active or inactive phase.
Key exclusion criteria (2 listed)
- Other primary headaches
- Subjects without social insurance
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 |
|---|---|---|
| Neurological clinical examinationDiagnostic and description of cluster headache | Other | Patient with Cluster headache |
| Psychological clinical examinationScale and questionnaires | Other | Patient with Cluster headache |
| QuestionnairesPsychopathological and cognitive questionnaires | Other | Patient with Cluster headache |
| Blood sampleBlood sample for DNA collection | Other | Patient with Cluster headache |
| Endothelial function measurementEndothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device | Other | Patient with Cluster headache |
Primary outcome
Duration of active periods of cluster headache
Time frame: Day 0 (Inclusion visit)
Number of active periods
Time frame: Day 0 (Inclusion visit)
Duration of cluster headache
Time frame: Day 0 (Inclusion visit)
Severity of attacks
Time frame: Day 0 (Inclusion visit)
Duration of active periods of cluster headache
Time frame: one year after inclusion
Number of active periods
Time frame: one year after inclusion
Duration of cluster headache
Time frame: one year after inclusion
Severity of attacks
Time frame: one year after inclusion
5 secondary outcomes
Existence of an addiction
Time frame: Day 0 (Inclusion visit)
Existence of an addiction
Time frame: One year after inclusion
Severity of Addiction
Time frame: Day 0 (Inclusion visit)
Severity of Addiction
Time frame: One year after inclusion
Reactive Hyperemic Index (RHI)
Time frame: Day 0 (Inclusion visit)
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 31 Mar 2022.
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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?
An observational study of Cluster Headache, run by University Hospital, Bordeaux at 1 site in France.
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 1 inclusion and 2 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 31 Mar 2022. 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 France. 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?
Duration of active periods of cluster headache (time frame: Day 0 (Inclusion visit)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.