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

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.

Study Overview

• Status: Completed
• Conditions: Role-expectancy on Patient Reported Outcomes
• Intervention / Treatment: Behavioral: cover story

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.

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • UKE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Migraine Patient; 122 migraine patients assigned the role of "patient"	Behavioral: cover story; After agreeing to participate, migraine patients were randomly given the briefing information and therefore their group allocation. Patients received the cover stories via the allocated flyer with study information and also by the physician from the outpatient clinic. Fifty percent of patients (Migraine as Patients [MP]) received the information that they will take part in a migraine study (compared to healthy controls) and that this study would investigates migraine associated dizziness by watching a visual stimulus (roller coaster video). The protocol for the intervention was standardized and identical for all participants. The other 50% (Migraine as Healthy [MH]) received the information that this study was in cooperation with the University's vertigo Department and that they will take part as controls since they were healthy apart from their migraine.
Experimental: Migraine Healthy; 122 migraine patients assigned the role of "healthy participant"	Behavioral: cover story; After agreeing to participate, migraine patients were randomly given the briefing information and therefore their group allocation. Patients received the cover stories via the allocated flyer with study information and also by the physician from the outpatient clinic. Fifty percent of patients (Migraine as Patients [MP]) received the information that they will take part in a migraine study (compared to healthy controls) and that this study would investigates migraine associated dizziness by watching a visual stimulus (roller coaster video). The protocol for the intervention was standardized and identical for all participants. The other 50% (Migraine as Healthy [MH]) received the information that this study was in cooperation with the University's vertigo Department and that they will take part as controls since they were healthy apart from their migraine.
No Intervention: headache-free controls; 122 headache-free controls with no cover story

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-reported vestibular symptoms	Patients were encouraged to describe their symptoms according to the Barany's Classification of Vestibular Disorders including its form (internal/external vertigo, dizziness or postural symptoms). Outcome was frequency of occurence of vestibular symptoms classified according to the Barany's Classification.	1 time point: study day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
differences in motion sickness susceptibility using a standardized motion sickness questionnaire	Motion sickness susceptibility was tested using the MSSQ- short version questionnaire. The outcome is a sum score.	1 time point: study day1
differences in disability level using a standardized motion sickness questionnaire	The disability level related to vestibular symptoms was assessed using the Dizziness Handicap Inventory (DHI-G). The outcome is a sum score.	1 time point: study day1
differences in headache days per month	The self-report of headache frequency/month was tested.	1 time point: study day1
differences in headache burden and migraine disability questionnaires	All participants filled out a questionnaire (migraine disability assessment score - MIDAS) The outcome is a sum-score	1 time point: study day1

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Hauke Basedau, MD, University Clinic Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: outcomes; migraine; role expectation; social role; response bias; subjective pain reporting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: beingapatient

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers meeting the criteria for access to confidential data may access the data upon request, involving the documentation of data access
• IPD Sharing Time Frame: once study is published
• IPD Sharing Access Criteria: researchers of govermental funded Universities (no commercial companies)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No