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Functionality of the Migraine Brain; a prospective fMRI study

Functionality of the Migraine Brain; a prospective fMRI study - Functionality of the Migraine Brain

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35187
Enrollment
40
Registered
2011-11-09
Start date
2011-11-10
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

headache Migraine

Interventions

None listed

Sponsors

Neurologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Migraineurs Inclusion criteria; i) Female migraine patients, suffering from menstrually related migraine according to IHS criteria; ii) in total, 1-2 attacks of migraine per month; iii) aged between 18-50 years; iv) provided written informed consent; v) preferable, no use of acute anti migraine medication during the study* and vi) a regular menstrual cyclus.;Healthy controls Inclusion criteria; i) Having a regular menstrual cycle; ii) aged between 18-50 years; iii) provided written informed consent;

Exclusion criteria

Exclusion criteria: Migraineurs Exclusion criteria: i) other neurological or psychiatric disease; ii) contraindications for being in a MR-scanner; iii) use of medications that may influence brain functioning (antidepressants; sedatives); iv) use of prophylactic antimigaine medication; v) presence of premenstrual syndrome; vi) having undergone procedures that influence regularity of menstrual cyclus, such as ovariectomy and hysterectomy; and vii) use of (oral) contraceptives.;Healthy controls Exclusion criteria: i) any neurological or psychiatric disease, including primary headache syndrome; ii) headache prior to menstrual flow; iii) contraindications for being in a MR-scanner; iv) use of medications that may influence brain functioning (antidepressants; sedatives); v) symptoms of premenstrual syndrome; vi) having undergone procedures that influence regularity of menstrual cyclus, such as ovariectomy and hysterectomy; vii) using medication that is also prescribed for migraine prophylaxis (ß-blokkers etc.), and viii) use of (oral) contraceptives.

Design outcomes

Primary

MeasureTime frame
Outcome parameters: - MR: RSN measurements: Time-dependent changes in neuronal activity as reflected by the BOLD signal in several functional networks; Time-dependent changes in regions; (voxel-wise) functional connectivity. - Cognitive tests: results of global-local task - Venapuncture: levels of female hormones (LH, FSH, oestrogen) - Questionnaires: information on presence/ absence of premonitory symptoms and headache

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)