How Can we Treat Photophobia in Migraine

NCT05369910 | Completed

• 1 other identifier: KLI 455
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders; Photophobia

Keywords

migraine; photophobia; habituation; headache; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Change from baseline interictal photophobia during and after the interventions

  Subjective sensitivity to light between migraine attacks is assessed using a numeric rating scale with the range from 0 (= no photophobia) to 10 (= max. photophobia). The numeric rating scale is daily completed by the participants over the study course using a structured diary. Daily reports are averaged for the duration of the baseline phase (7 days before the first intervention starts), for the duration of the interventions (Flash and Dark, 7 days each), and for 7 days after the interventions (Post Flash, Post Dark).

  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 (3)

• Change from baseline headache frequency during and after the interventions

  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).

• Change from baseline headache severity during and after the interventions

  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).

• Change from baseline ictal photophobia during and after the interventions

  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 (1)

• Change from baseline functional activation in the primary visual cortex after the interventions

  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.

Study Arms (2)

Flash first

EXPERIMENTAL

Light exposure (Flash) first, light deprivation (Dark) second: Both interventions (Flash and Dark) are administered for one hour on 7 consecutive days. During the light exposure, participants are seated 120 cm in front of a white curtain that is illuminated by an LED light source. During the light deprivation, participants are seated in the same room used for light exposure, but in complete darkness.

Behavioral: Light exposure (Flash); Behavioral: Light deprivation (Dark)

Dark first

EXPERIMENTAL

Light deprivation (Dark) first, Light exposure (Flash) second: Both interventions (Flash and Dark) are administered for one hour on 7 consecutive days. During the light exposure, participants are seated 120 cm in front of a white curtain that is illuminated by an LED light source. During the light deprivation, participants are seated in the same room used for light exposure, but in complete darkness.

Behavioral: Light exposure (Flash); Behavioral: Light deprivation (Dark)

Interventions

Light exposure (Flash) BEHAVIORAL

Light exposure (Flash) is administered for one hour on 7 consecutive days. During the light exposure, participants are seated 120 cm in front of a white curtain that is illuminated by an LED light source (Dawe stroboscope type 1214B, 5 Hz).

Dark first; Flash first

Light deprivation (Dark) BEHAVIORAL

Light deprivation (Dark) is administered for one hour on 7 consecutive days. During the Dark intervention, participants are seated in a room in complete darkness.

Dark first; Flash first

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients:
• Migraine without aura according to the criteria of the International Classification of Headache Disorders (ICHD-3 beta)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Austrian Science Fund (FWF): collaborator

Related Publications (1)

• 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.

  PMID: 35948966 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Photophobia; Substance-Related Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Pain

Study Officials

• Roland Beisteiner, MD

  Department of Neurology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions, no blinding is possible, but both Flash and Dark interventions are presented as equivalently treatment options.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 11, 2022
• Study Start: April 1, 2015
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share