Imaging the Migraine Brain Pre- and Post-Erenumab
- Registration Number
- NCT03773562
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are trying to determine if there is a difference between brain images of subjects that do respond to treatment with erenumab and subjects who do not respond to treatment with erenumab using Magnetic Resonance Imaging (MRI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erenumab Erenumab All participants receive erenumab 140mg by subcutaneous injection at baseline and again 4 weeks later.
- Primary Outcome Measures
Name Time Method Resting State Functional Connectivity 8 weeks Brain MRI resting state functional connectivity measured as global efficiency percentage. An increase in global efficiency suggests an improvement in the ability of the brain regions to functionally communicate on a global scale. Efficiency relates to the network. In this case, the investigators defined the network to be the pain matrix. Increased efficiency would mean the connectivity within the matrix is increased and more efficient. This has not been attributed to a clinical outcome but is rather a characteristic of the network.
- Secondary Outcome Measures
Name Time Method ROI-ROI Functional Connectivity of Dorsolateral Prefrontal Cortex Left With Hypothalamus Right 8 weeks Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range \[ -1 to 1\]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from \[-1 1\] to a real number \[ -infinity infinity\] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity.
Erenumab Responders 8 weeks The number of participants who responded to erenumab treatment. Treatment response was defined as at least a 50% reduction in the frequency of migraine days during weeks 5-8 compared to the 4 week pre-treatment run-in phases as recorded in the headache diary.
ROI-ROI Functional Connectivity of Middle Temporal Left With Supramarginal Gyrus Right Regions of the Brain 8 weeks Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range \[ -1 to 1\]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from \[-1 1\] to a real number \[ -infinity infinity\] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity.
ROI-ROI Functional Connectivity of Temporal Pole Right With Middle Occipital Right 8 weeks Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range \[ -1 to 1\]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from \[-1 1\] to a real number \[ -infinity infinity\] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity.
ROI-ROI Functional Connectivity of Ventromedial Prefrontal Cortex Left With Pulvinar Right 8 weeks Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range \[ -1 to 1\]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from \[-1 1\] to a real number \[ -infinity infinity\] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity.
Iron Accumulation in Anterior Cingulate Cortex Brain Region 8 weeks Iron accumulation in the anterior cingulate cortex as measured by magnetic resonance imaging (MRI) transverse relaxation rates (T2\*).
Change in the Migraine Disability Assessment Questionnaire (MIDAS) Baseline, 8 weeks The MIDAS questionnaire consists of 5 questions that assess the degree of headache related disability. Each question asks the patient to record the number of days in the past 3 months where a headache has impacted various daily life activities. The individual responses to each of the five questions are then added to obtain a total score and level of disability. A total score of 0-5 days reflects little or no disability (Grade I); 6-10 days is mild disability (Grade II); 11-20 days is moderate disability (Grade III) and over 21 days is severe disability (Grade IV). A lower score indicates less disability while a higher score reflects more disability.
Iron Accumulation in Periaqueductal Gray Brain Region 8 weeks Iron accumulation in the periaqueductal gray as measured by magnetic resonance imaging (MRI) transverse relaxation rates (T2\*).
ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Middle Frontal Left 8 weeks Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range \[ -1 to 1\]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from \[-1 1\] to a real number \[ -infinity infinity\] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity.
ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Supramarginal Gyrus Right 8 weeks Temporal correlations in blood oxygen level dependent (BOLD) signal fluctuations between selected regions of interest (ROIs). The correlation coefficient ( r ) is measured between seed regions. This measurement is bound by the range \[ -1 to 1\]. In order to perform statistical tests (such as T-tests) we Fisher transform the correlation coefficient from \[-1 1\] to a real number \[ -infinity infinity\] Mathematically it is: z=atanh( r ). The Z-score themselves are functional connectivity between the regions and do not serve as clinical biomarkers. The difference, and longitudinal changes are of greater interest as they indicate alterations to normal pain processing. A more efficient pain processing network would suggest that more of these regions are being enlisted and with greater connectivity.
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States