Clinical trial NCT05369910: How Can we Treat Photophobia in Migraine
Official title: How Can we Treat Photophobia in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Photophobia
Keywords: migraine
photophobia
habituation
headache
functional magnetic resonance imaging
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Austrian Science Fund (FWF)
First posted: 2022-05-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants receive light exposure therapy (Flash) and light deprivation therapy (Dark) for one hour daily on 7 consecutive days, in a crossover design with a wash-out period of 3 months. The sequence of the interventions is randomly allocated.
Primary purpose: TREATMENT

Brief summary: Photophobia, the aberrantly increased sensitivity to light, is a common symptom in migraine patients and light discomfort is frequently found as a trigger for migraine attacks. In behavioral studies, planned exposure to light was found to reduce headache in migraineurs with photophobia, potentially by increasing habituation to this migraine trigger. Here, neurophysiological mechanisms of light exposure versus light deprivation therapy in migraine patients are investigated using functional magnetic resonance imaging (fMRI).

Migraine patients and healthy controls receive light exposure therapy (Flash) and light deprivation therapy (Dark) for one hour daily on 7 consecutive days, in a crossover design with a wash-out period of three months. Study participants keep a diary including items on interictal and ictal photophobia, headache frequency and severity 7 days before, during, and 7 days after the interventions. One week before and one day after both interventions, fMRI using flickering light in a block design is applied. Functional activation is analyzed at whole-brain level and habituation of the visual cortex (V1) is modeled with the initial amplitude estimate and the corrected habituation slope.


Eligibility criteria: Inclusion Criteria:

Patients:

* Migraine without aura according to the criteria of the International Classification of Headache Disorders (ICHD-3 beta)
* 1-4 days with migraine per month in the preceding last 3 months
* A score between 2 and 6 on a numeric rating scale for the intensity of interictal photophobia (range from 0 to 10 (= max. intensity))
* A score \>4 for ictal photophobia

Controls

* No personal or family history of migraine
* A score \<2 for photophobia

Exclusion Criteria:

* Current or previous circadian rhythm disorders
* Current or previous major depression
* Current or previous anxiety disorders
* Current or previous medication overuse
* Besides migraine in the patient group, participants should not suffer from any other recurrent headache apart from infrequent tension-type headaches

Primary outcomes:
measure: Change from baseline interictal photophobia during and after the interventions
timeFrame: Change in interictal photophobia during the interventions (Flash and Dark, average over 7 days) and after the interventions (Post Flash, Post Dark, average over 7 days) relative to the baseline (average over 7 days before the first intervention starts).
Secondary outcomes:
measure: Change from baseline headache frequency during and after the interventions
timeFrame: Change in headache frequency during the interventions (Flash and Dark, average over 7 days) and after the interventions (Post Flash, Post Dark, average over 7 days) relative to the baseline (average over 7 days before the first intervention starts).
measure: Change from baseline headache severity during and after the interventions
timeFrame: Change in headache severity during the interventions (Flash and Dark, average over 7 days) and after the interventions (Post Flash, Post Dark, average over 7 days) relative to the baseline (average over 7 days before the first intervention starts).
measure: Change from baseline ictal photophobia during and after the interventions
timeFrame: Change in ictal photophobia during the interventions (Flash and Dark, average over 7 days) and after the interventions (Post Flash, Post Dark, average over 7 days) relative to the baseline (average over 7 days before the first intervention starts).
Other outcomes:
measure: Change from baseline functional activation in the primary visual cortex after the interventions
timeFrame: fMRI one day after the completion of each intervention (Flash, Dark) is compared the the baseline fMRI measured 7 days before the first intervention starts.
Locations:
Study officials:
affiliation: Department of Neurology, Medical University of Vienna
name: Roland Beisteiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matt E, Aslan T, Amini A, Saricicek K, Seidel S, Martin P, Wober C, Beisteiner R. Avoid or seek light - a randomized crossover fMRI study investigating opposing treatment strategies for photophobia in migraine. J Headache Pain. 2022 Aug 11;23(1):99. doi: 10.1186/s10194-022-01466-0.