Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial

Overview

This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there) Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls.

We have a three group randomized controlled design. Migraine patients from the headache outpatient clinic will randomly be assigned to get two different cover stories via a flyer with study information and through the physician from the outpatient clinic: 50% of patients will receive the information that they will take part to investigate migraine (by watching the visual stimulus (roller coaster video)). The other 50% will receive the information that they will take part as healthy controls for a headache unrelated study (by watching the visual stimulus (roller coaster video)). Sex and age matched healthy controls will take part in the same experiment and get no additional information but that we investigate the perception of a visual stimulus (roller coaster video). The protocol for the intervention is standardized and identical for all participants. Migraine patients will be randomly given the priming information and therefore their group allocation. Physicians will allocate by pulling from a randomized equally sized stock of flyers (of which 50% inform for healthy controls and 50% for migraine patients). Migraine Patients for both migraine groups will be recruited and diagnosed by a neurologist from the UKE headache outpatient clinic. Healthy controls will be recruited via an internet platform for job advertisement. Participants will be paid 10€ for participation. Participants must be at least 18 years old and have signed the informed consent. They are excluded if they have 1. History of any neurological disease, 2. Self-report of diagnosis of vestibular disease, 3. History of trauma or pathology of the cervical spine (e.g., whiplash associated disorder), 4. Pregnancy, 5. Other relevant musculoskeletal, systemic or psychiatric disease.