An observational study in Cluster Headache, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Thomas Jefferson University · Observational
This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 41 is below the median of 68 across 32 observational studies indexed under Cluster Headache.
Browse Cluster Headache studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with cluster headache
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
Other: There are no interventions in the observational study. The symptom of allodynia was measured.
No intervention. Description of allodynia testing appears elsewhere in this document
Prevalence of Allodynia in Subjects With Cluster Headache
Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.
Time frame: Allodynia was assessed at the screening visit
Subjects with cluster headache recruited from Jefferson Headache Center office practice or community. First subject enrolled 7/5/05. Last subject enrolled 6/9/06.
| Milestone | Subjects With Cluster Headache |
|---|---|
| Started | 41 |
| Completed | 41 |
| Not completed | 0 |
Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.
| participants | Subjects With Cluster Headache |
|---|---|
| Prevalence of Allodynia in Subjects With Cluster Headache | 20 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Cluster Headache | — | 0/41 (0%) | 0/41 (0%) |
| Age, Categorical(Participants) | Subjects With Cluster Headache |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 41 |
| >=65 years | 0 |
| Age, Continuous(years) | Subjects With Cluster Headache |
|---|---|
| Mean | 44.9 ± 10.5 |
| Sex: Female, Male(Participants) | Subjects With Cluster Headache |
|---|---|
| Female | 19 |
| Male | 22 |
| Region of Enrollment(participants) | Subjects With Cluster Headache |
|---|---|
| United States | 41 |
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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