Trial document




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  DRKS00007739

Trial Description

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Title

How can we treat photophobia in migraine?
A functional imaging investigation of two opposing concepts

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Increased sensitivity to light (photophobia) is a hallmark of migraine which often precipitates headache attacks and handicaps patients by forcing them into a darkened room. Currently it is not known how to treat this stressing symptom and even two directly opposing treatment concepts exist: reduction of light exposure versus desensitisation via controlled exposure. This study will generate the first comprehensive data about the best treatment approach by comparing both strategies directly in the same patients. Besides clinical evaluation, effects of both treatments on subjects brains will be monitored by functional magnetic resonance imaging (fMRI). With such data, a neurophysiologically based recommendation for future effective treatment of photophobia will become possible.

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Organizational Data

  •   DRKS00007739
  •   2015/01/30
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  •   yes
  •   Approved
  •   EK-Nr. 1827/2013, Ethikkommission der Medizinischen Universität Wien
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Secondary IDs

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Health Condition or Problem studied

  •   G43.9 -  Migraine, unspecified
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Interventions/Observational Groups

  •   Light Deprivation Condition:

    Day 0: baseline fMRI
    Day 1-7: exposition to 1 h complete darkness per day (12.00 – 1.00 p.m.)
    Day 8: postintervention fMRI
  •   Light Desensitization Condition:

    Day 0: baseline fMRI
    Day 1-7: exposition to 1 h flickerlight (5 Hz) per day (12.00 – 1.00 p.m.)
    Day 8: postintervention fMRI
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

a. Difference in mean total (i.e. ictal and interictal) sensitivity to light in the week after
the intervention (days 8 – 14) between light exposure and light deprivation in
patients with migraine

b. Change in mean total sensitivity to light in the week after light exposure (days 8 –
14) compared to baseline (days -7 – -1) in patients with migraine

c. Change in mean total sensitivity to light in the week after light deprivation (days 8
– 14) compared to baseline (days -7 – -1) in patients with migraine

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Secondary Outcome

a. Differences in mean interictal and mean ictal sensitivity to light in the week after
the intervention (days 8 – 14) between light exposure and light deprivation in
patients with migraine

b. Changes in mean interictal and mean ictal sensitivity to light in the week after light
exposure (days 8 – 14) compared to baseline (days -7 – -1)

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Patients:

o Migraine without aura according to the criteria of ICHD-III beta
o Migraine present on 1 and 4 days per month in the 3 months preceding study
inclusion
o Intensity of interictal sensitivity to light 2 – 6 on a numeric rating scale with
range 0-10
o Intensity of ictal sensitivity to light >4 on a numeric rating scale a numeric
rating scale with range 0-10

Controls:

o Matched for age, sex, education and socioecomic status to patients
o No personal or family history of migraine
o sensitivity to light <2 on a numeric rating scale

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Exclusion Criteria

o Any other recurrent current or previous headache disorder apart from infrequent
tension-type headache
o Current or previous medication overuse
o Pregnancy
o Photosensitive epilepsy (excluded by a routine EEG)
o Other current or previous brain disorders
o Ophthalmological disorders relevant to the study
o Psychiatric disorders relevant to the study
o Other diseases relevant to the study including circadian rhythm disorders
o Regular intake of centrally acting compounds including prophylactic medication for
headache in the preceding three months
o Shift and / or night work
o Regular stay in unusually dark or bright environments
o Light therapy within the preceding 3 months
o Strategies to avoid exposure to light within the preceding 3 months
o Claustrophobia
o Metallic implants preventing fMRI
o Current or history of substance abuse
o Any other fMRI contraindications

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Addresses

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    • Universitätsklinik für NeurologieMedizinische Universität Wien
    • 1090  Wien
    • Austria
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    • Universitätsklinik für NeurologieMedizinische Universität Wien
    • Mr.  Univ.-Prof. Dr.  Roland  Beisteiner 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • Universitätsklinik für NeurologieMedizinische Universität Wien
    • Mr.  Univ.-Prof. Dr.  Roland  Beisteiner 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • FWF Der Wissenschaftsfonds Haus der Forschung
    • Sensengasse 1
    • 1090  Wien
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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