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出境医 / 临床实验 / Neurophysiology of Prophylactic Treatment in Migraine
Neurophysiology of Prophylactic Treatment in Migraine
Study Description
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 |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 44 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 |
| Actual Primary Completion Date : | May 2, 2021 |
| Actual Study Completion Date : | May 2, 2021 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
- somatosensory evoked potentials (SSEP) [ Time Frame: baseline and after 3 months ]habituation of the N20 SSEP component following bilateral median nerve stimulation
- pattern-reversal visual evoked potentials (VEP) [ Time Frame: baseline and after 3 months ]habituation of the P100 VEP component following bilateral optic nerve stimulation
- migraine headache frequency [ Time Frame: baseline and after 3 months ]days with migraine headaches during the last month
- headache impact test (HIT-6) [ Time Frame: baseline and after 3 months ]impact of migraine severity on daily routine
- migraine disability assessment (MIDAS) [ Time Frame: baseline and after 3 months ]impact of migraine frequency on daily routine
- 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:
- 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
- electroencephalography (EEG) [ Time Frame: baseline and after 3 months ]EEG connectivity following nociceptive and sensory stimulation
- 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)
- functional magnetic resonance imaging (fMRI) [ Time Frame: baseline and after 3 months ]resting-state connectivity of networks involved in central pain processing
Eligibility Criteria
| 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.
Criteria
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
Contacts and Locations
Locations
| Germany | |
| Department of Neurology | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17475 | |
Sponsors and Collaborators
University Medicine Greifswald
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 10, 2019 | ||||
| First Posted Date | July 15, 2019 | ||||
| Last Update Posted Date | May 27, 2021 | ||||
| Actual Study Start Date | January 29, 2019 | ||||
| Actual Primary Completion Date | May 2, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
|
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title | Neurophysiology of Prophylactic Treatment in Migraine | ||||
| Official Title | Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition | Migraine | ||||
| Intervention | 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
|
||||
| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
44 | ||||
| Original Estimated Enrollment |
50 | ||||
| Actual Study Completion Date | May 2, 2021 | ||||
| Actual Primary Completion Date | May 2, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria (migraineurs):
Exclusion Criteria (migraineurs):
Inclusion criteria (controls):
exclusion criteria (controls):
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04019496 | ||||
| Other Study ID Numbers | BB168/18 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Medicine Greifswald | ||||
| Study Sponsor | University Medicine Greifswald | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Medicine Greifswald | ||||
| Verification Date | May 2021 | ||||
