Clinical trial NCT06322550: Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial
Official title: Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Role-expectancy on Patient Reported Outcomes
Keywords: migraine
role expectation
outcomes
social role
response bias
subjective pain reporting
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocenter, randomized, double blind, three-armed clinical trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* migraine patients following ICHD-3 criteria
* headache free controls

Exclusion Criteria:

* any other headache or pain disorder
* known somatic or psychiatric disorder
* pregnacy or breast feeding
* known vestibular disorder or whiplash injury

Primary outcomes:
measure: self-reported vestibular symptoms
timeFrame: 1 time point: study day1
Secondary outcomes:
measure: differences in motion sickness susceptibility using a standardized motion sickness questionnaire
timeFrame: 1 time point: study day1
measure: differences in disability level using a standardized motion sickness questionnaire
timeFrame: 1 time point: study day1
measure: differences in headache days per month
timeFrame: 1 time point: study day1
measure: differences in headache burden and migraine disability questionnaires
timeFrame: 1 time point: study day1
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: UKE
Study officials:
affiliation: University Clinic Hamburg
name: Hauke Basedau, MD
role: PRINCIPAL_INVESTIGATOR
References: