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Trial record 20 of 36 for:    fmri headache

Neurophysiology of Prophylactic Treatment in Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04019496
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : August 2, 2019
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:

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.

Condition or disease Intervention/treatment
Migraine Drug: antibodies against calcitonin-gene related peptide or its receptor

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Calcitonin

Group/Cohort Intervention/treatment
Episodic Migraine Drug: antibodies against calcitonin-gene related peptide or its receptor
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

Healthy controls
equal to or less than 1 headache day/month

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients seen in the local headache clinic are screened for eligibility to participate the study. Clinical routine is not influenced by participation in this observational study, importantly choice of prophylactic treatment solely depends on the physician's and patient's decision based on national guidelines.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04019496

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Contact: Robert Fleischmann, MD +493834866855

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Department of Neurology Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Contact: Robert Fleischmann, MD    +49-3834 86-6855   
Principal Investigator: Robert Fleischmann, MD         
Principal Investigator: Martin Kronenbürger, MD         
Sub-Investigator: Sebastian Strauß, MD         
Sub-Investigator: Anne Thiele         
Sponsors and Collaborators
University Medicine Greifswald

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Responsible Party: University Medicine Greifswald Identifier: NCT04019496     History of Changes
Other Study ID Numbers: BB168/18
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medicine Greifswald:
blink reflex
functional magnetic resonance imaging
evoked potentials
Additional relevant MeSH terms:
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Headache Disorders, Primary
Headache Disorders
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcitonin Gene-Related Peptide
Immunologic Factors
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Vasodilator Agents