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NCT Number: NCT04019496

Neurophysiology of Prophylactic Treatment in Migraine

This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype.

The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(migraineurs):

  • episodic migraine according to ICHD (international classification of headache disorders)-3 criteria
  • headache documented over at least 3 months through a headache calender
  • scheduled for prophylactic therapy of their migraine

Exclusion criteria

(migraineurs):

  • history of chronic migraine
  • current medication-overuse headache
  • neurological or psychiatric diagnosis other than headaches
  • chronic intake of central nervous system active drugs (antidepressants, antipsychotics etc.)
  • contraindications for magnetic resonance imaging
  • contraindications for transcranial magnetic stimulation

Inclusion criteria

(controls):

  • not more than 3 years younger or older than matched control
  • gender similar to matched control
  • menstrual cycle equal to matched control (if female)

Exclusion criteria

(controls):

  • more than 1 headache day/month
  • history of migraine

Treatment and study plan

antibodies against calcitonin-gene related peptide or its receptor

Drug

the study is observational and does not interfere with clinical routine. In lin with this notion, the intervention is chosen by the treating physician in a shared decision making process involving the patient

Primary outcomes

  1. nociceptive blink reflex habituation

    Time frame: baseline and after 3 months

    habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches

Secondary outcomes

  1. nociceptive blink reflex area

    Time frame: baseline and after 3 months

    area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches

  2. somatosensory evoked potentials (SSEP)

    Time frame: baseline and after 3 months

    habituation of the N20 SSEP component following bilateral median nerve stimulation

  3. pattern-reversal visual evoked potentials (VEP)

    Time frame: baseline and after 3 months

    habituation of the P100 VEP component following bilateral optic nerve stimulation

  4. migraine headache frequency

    Time frame: baseline and after 3 months

    days with migraine headaches during the last month

  5. headache impact test (HIT-6)

    Time frame: baseline and after 3 months

    impact of migraine severity on daily routine

  6. migraine disability assessment (MIDAS)

    Time frame: baseline and after 3 months

    impact of migraine frequency on daily routine

  7. Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)

    Time frame: baseline and after 3 months

    multi domain patient reported quality of life

Other outcomes

  1. transcranial magnetic stimulation (TMS)

    Time frame: baseline and after 3 months

    input-output curves of motor evoked potential following single and double-pulse navigated TMS to the side stimulated during the nociceptive blink reflex examination

  2. electroencephalography (EEG)

    Time frame: baseline and after 3 months

    EEG connectivity following nociceptive and sensory stimulation

  3. structural magnetic resonance imaging (sMRI)

    Time frame: baseline and after 3 months

    volumetry of brain structures involved in central pain processing (e.g. cingulate cortex, insula, thalamus)

  4. functional magnetic resonance imaging (fMRI)

    Time frame: baseline and after 3 months

    resting-state connectivity of networks involved in central pain processing

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2019
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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