How Can we Treat Photophobia in Migraine

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT05369910

Collaborator

Austrian Science Fund (FWF) (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders Photophobia	Behavioral: Light exposure (Flash) Behavioral: Light deprivation (Dark)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Masking Description:

Due to the nature of the interventions, no blinding is possible, but both Flash and Dark interventions are presented as equivalently treatment options.

Primary Purpose:

Treatment

Official Title:

How Can we Treat Photophobia in Migraine

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flash first 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) 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). Behavioral: Light deprivation (Dark) 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.
Experimental: Dark first 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) 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). Behavioral: Light deprivation (Dark) 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.

Arm

Intervention/Treatment

Experimental: Flash first

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)

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).

Behavioral: Light deprivation (Dark)

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.

Experimental: Dark first

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)

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.

Outcome Measures

Primary Outcome Measures

Change from baseline interictal photophobia during and after the interventions [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).]
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).

Secondary Outcome Measures

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).]
In the structured diary, the participants report if a headache is present (1) or absent (0). 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 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).]
If a headache is present that day, questions regarding headache severity (mild (1), moderate (2), severe (3)) are completed in the 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 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).]
If a headache is present that day, photophobia during the headache is assessed on a numeric rating scale with the range from 0 (= no photophobia) to 10 (= max. photophobia). 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).

Other Outcome Measures

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.]
3 Tesla functional Magnetic Resonance Imaging (fMRI) is used to analyze brain activation induced by flickering light (10 functional runs, block design with 7 alternating blocks (20 s each) of flashing light (8 Hz) and darkness (140 s per run)).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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