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Chronification Of migraine and Pain Experience

Recruiting
Conditions
Migraine chronic and episodic
Registration Number
NL-OMON24226
Lead Sponsor
/A
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

General inclusion:
- age between 18 and 75 years
- able to provide written informed consent
Chronic migraine: diagnosed with chronic migraine and medication overuse according to IHS 3-ß criteria
Episodic migraine:- diagnosed with migraine with or without aura according to IHS 3-ß criteria
- 1 or 2 migraine attacks per month, with a cumulative duration of = 6 migraine-days and = 10 headache days per month.

Exclusion Criteria

General exclusion:
- Neurological conditions, such as peripheral neuropathy or epilepsy, other than
the specific types described in the group specific inclusion criteria;
- Any (chronic) pain condition of moderate to severe intensity, or requiring pain medication, other than the types described in the group specific inclusion criteria;
- Psychiatric disease, such as psychosis, other than mild to moderate depression and anxiety, which in the opinion of the investigators may interfere with the study;
- Other medical disease such as pulmonary renal, liver, cardiac, gastro-intestinal, vascular disease, which in the opinion of the investigators may interfere with the study;
- Regular use of non-triptan or non-analgesic acute anti-headache medication (e.g. ergots, high dose opioids, barbiturates) or high dose benzodiazepines;
- Change in use of TCAs (a.o. amitriptyline, clomipramine, dosulepin, doxepin, imipramine, nortriptyline, maprotiline), SNRIs (a.o. high dose duloxetine / venlafaxine, trazodone), or calcium channel inhibitors (a.o. pregabalin, gabapentin) in the past three months.
- Current abuse of, or history of abuse of alcohol, soft drugs or hard drugs, which in the opinion of the investigators may interfere with the study;
- Use of contact lenses (current, or past for > three months) (Corneal Confocal Microscopy specific)
- Pregnancy or lactation;
- Enrolment in other studies that may confound the results of this study.

Chronic migraine: Headache syndrome other than described above as inclusion criteria.

Episodic migraine:
- Headache syndrome other than described above as inclusion criteria;
- A history of chronic migraine according to IHS 3-ß criteria;
- A history of medication overuse headache according to IHS 3-ß criteria.

Healthy controls:
- Headache syndrome according to IHS 3-ß criteria other than self-reported tension type headache = 4 days/month
- Regular use of pain medication (including acetaminophen and NSAIDs) for any condition.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Part A and part B<br>Primary outcome measurements for of the three aspects:<br>1. relative change in peak VAS score;<br>2. QST parameters;<br>3. corneal nerve fiber density.<br><br>Part C<br>- Headache frequency
Secondary Outcome Measures
NameTimeMethod
Part A and B<br>Secondary outcomes for each of the three aspects:<br>1. change in area under the curve (VAS*sec) of the test stimulus during the conditioned stimulus;<br>2. no additional outcomes;<br>3. corneal nerve fiber length and corneal nerve branch density.<br><br>Additional outcome measures:<br>- Sum scores on depression, anxiety and visual sensitivity questionnaires.<br><br>Part C<br>- migraine frequency
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