CompletedNot Applicable

Presence of Signs of Central Sensitization in Episodic and Chronic Migraine

Belgium60 participantsStarted 2021-10-15

Plain-language summary

Nowadays migraine is conceptualized as a continuum, with at the one hand episodic migraine (EM) and at the other hand chronic migraine (CM) (1). The general aim of the study is to determine where exactly in this continuum central sensitization (CS) appears. Recent studies support the presence of CS in migraine patients (2,3), but controversial evidence exists about where in the continuum exactly CS appears. Some studies determined no differences in sings of CS between EM and CM (4,5), whether other research indicate a clear difference between EM and CM (6-8). However a significant difference in CS parameters could be determined between a patient group (EM or CM) and a healthy control group (3,4,8). In addition, CS appears to be present during the migraine attack (2). In this research, the presence of signs of CS will be determined in between headache phases. The primary outcome measure is identification of CS by PPT, QST, TS, CPM and CSI. Secondary outcome measures are the outcome of the MIDAS, HADS and EUROLIGHT.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. diagnosis of migraine headache based on the criteria of ICDH-3 and verified by a medical doctor,
. not being pregnant or have given birth in the preceding year,
. adults between the age of 18 years and 65 years.

Exclusion criteria

. any other diagnosis of headache or mixed form,
. any structural neurological syndrome, 3) any neurological brain event in the past,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Extend of central sensitization by quantitative sensory testing (QST) in °C.

Timeframe: at baseline

Extend of Central sensitization by central sensitization inventory (CSI) as a scale

Timeframe: at baseline

Trial details

NCT IDNCT05162664

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01

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