Autonomic nervous system function in adolescent migraineurs.
Seiji Yoshida, Hidetaka Tanaka, Midori Mizutani...
https://pubmed.ncbi.nlm.nih.gov/28612516/Actively Recruiting
Led by Medical University of Vienna · Updated on 2024-12-10
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are investigating how the autonomic nervous system functions in people with migraine and how it may change depending on whether they are between or during migraine attacks. The study also explores whether drugs called CGRP monoclonal antibodies, which block a messenger substance involved in migraine development, affect autonomic nervous system functions. Migraines are common and disabling, and while CGRP antibodies have been shown to reduce migraine frequency, their impact on autonomic functions is not well understood. The study involves patients with episodic or chronic migraine who have not responded to standard preventive medications, as well as healthy control participants without migraine or chronic disease. Patients will be observed over five months, including baseline visits and an evaluation visit, during which autonomic function scores will be measured and compared before and during treatment with anti-CGRP monoclonal antibodies such as Erenumab, Galcanezumab, or Fremanezumab. Controls will have one testing visit and a follow-up call. Participants will undergo standardized autonomic function tests measuring cardiovagal autonomic dysfunction and complete questionnaires assessing migraine impact, autonomic symptoms, quality of life, and psychiatric symptoms. These evaluations will occur at baseline, during migraine attack phases, and after five months of treatment or observation. Researchers will monitor changes in autonomic function scores and migraine-related questionnaires to understand the effects of migraine status and CGRP inhibition over time.
CONDITIONS
CGRP Inhibition, Autonomic Function, and Migraine
A
Antun R Pavelic, MD
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Medical University of Vienna
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are evaluated for eligibility based on medical history and inclusion/exclusion criteria.
Duration - Up to 1 month
Participants undergo initial clinical assessments to establish baseline autonomic function and migraine status.
1 to 2 clinical visits including a baseline visit on Day 0 and an additional visit between Days 1 and 30.
Duration - Up to 1 month
Participants with migraine are observed during different migraine phases to assess autonomic function off prophylactic medication, including ictal and peri-ictal phases. Healthy controls undergo one testing visit.
Migraine patients: multiple assessments within Days 1 to 31. Healthy controls: 1 testing visit on Day 0.
Duration - 5 months
Participants receiving anti-CGRP monoclonal antibodies are observed over 5 months to evaluate changes in autonomic function during treatment.
1 evaluation visit at Month 5 (End of Study) plus telephone follow-up.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/30887872/Medical University of Vienna
Lead Sponsor