How Can we Treat Photophobia in Migraine

NCT ID: NCT05369910

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2019-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Light exposure (Flash)

Intervention Type: 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).

Light deprivation (Dark)

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Light exposure (Flash)

Intervention Type: 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).

Light deprivation (Dark)

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Austrian Science Fund (FWF)

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Eva Matt

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland Beisteiner, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Medical University of Vienna

References

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.

Reference Type: DERIVED

PMID: 35948966 (View on PubMed)

Other Identifiers

KLI 455

Identifier Type: -

Identifier Source: org_study_id