Migraine Clinical Trial
Official title:
Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature
Migraine is a highly prevalent and disabling neurological disease, which has a tremendous impact on sufferers, healthcare systems, and the economy. According to the 2016 WHO report, migraine is the second leading cause of years lived with disability, greater than all other neurological diseases combined. Yet, the treatment in migraine is far from optimum; the sufferers often abuse painkillers and complicated with medication overuse headache. Migraine is characterized by the hypersensitivity of the sensory system, potentially attributed to dysfunctional pain modulatory networks located in the deep brain structures, particularly the brainstem. However, the current understanding of these deeply seated, dysregulated pain modulatory circuits in migraine is limited due to technological constraints. Besides, studies with an in-depth analysis of the clinical manifestations (i.e., deep phenotyping) are lacking, and there is no corresponding animal model readily available for translational research. In this project, the investigators propose a multimodal approach to address these issues by applying the technologies and platforms developed by our team to explore the correlation between pain sensitivity and dysregulated connectivities from brainstem to other brain regions. In this four-year project, the investigators will recruit 400 migraine patients and 200 healthy subjects. The investigators aim at decomposing the key brainstem mechanisms underlying dysmodulated pain sensitivity in migraine from 5 comprehensive perspectives: (1) clinical deep phenotyping, (2) high-resolution brainstem structural MRI and functional connectivity analysis, (3) innovative brainstem EEG signal detecting technique, (4) multimodal data fusion platform with neural network analysis, and (5) ultrahigh-resolution brainstem-based connectomes, intravital manipulations and recording, and connectome-sequencing in animal models. Moreover, the investigators will collaborate with Taiwan Semiconductor Research Institute to develop a wearable high-density EEG equipment, integrated with a System-on-Chip capable of edge-computing the signal using algorithms derived from our brainstem decoding platform. The ultimate goal is to build a real-time brainstem decoding system for clinical application.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Migraine: Inclusion criteria: 1. fulfill the diagnostic criteria of migraine in ICHD-3, 2. 20-65 yrs, 3. understand the study design and willing to join the study 4. at least four headache days per month, 5. the onset of headache is prior to 50 yrs., 6. normal neurological examination findings. Exclusion criteria: 1. history or family history of epilepsy, 2. taking migraine prophylactics, 3. women who are breastfeeding or pregnant, 4. severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia, 5. medical, neurological or psychiatric disease discovered by the researcher that would hinder the research, 6. contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…). Healthy: Inclusion criteria: 1. 20-65 yrs, 2. normal neurological examination findings, 3. understand the study design and willing to join the study. Exclusion criteria: 1. history or family history of epilepsy, 2. women who are breastfeeding or pregnant, 3. severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia, 4. medical, neurological or psychiatric disease discovered by the researcher that would hinder the research, 5. contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…), 6. history of headache will be included (the tension-type headache occurs < 1 time per month is allowed) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Headache Center, Teipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical change after treatment (1) headache frequency | clinical change (headache frequency) after treatment unit: attacks per month analysis: comparing the mean headache frequency in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0) | 6 months | |
Primary | Clinical change after treatment (2) headache intensity | clinical change (headache intensity) after treatment unit: NRS (numeric rating scale, 0-10) analysis: comparing the mean headache intensity in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0) | 6 months | |
Primary | Clinical change after treatment (3) headache duration | clinical change (headache duration) after treatment unit: hours/day analysis: comparing the mean headache duration (hours/day) in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0) | 6 months | |
Secondary | EEG change after treatment (1) Linear analysis of EEG before and after treatment | power spectral density change of EEG before and after treatment • Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months | |
Secondary | EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment | functional connectivity change of EEG before and after treatment • Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months | |
Secondary | EEG change after treatment (3) Nonlinear analysis of EEG before and after treatment | evoked potential amplitude change of EEG before and after treatment • Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months | |
Secondary | Sensory threshold change after treatment | Using quantitative sensory testing (QST) to evaluate the sensory threshold before and after treatment • Four standard QST sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months | |
Secondary | fMRI change after treatment (1) | functional connectivity change of fMRI before and after treatment • Three fMRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months | |
Secondary | fMRI change after treatment (2) | activation change of fMRI before and after treatment • Three fMRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months | |
Secondary | MRI change after treatment (1) | VBM changes of MRI before and after treatment • Three MRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months | |
Secondary | MRI change after treatment (2) | SBM changes of MRI before and after treatment • Three MRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively. |
12 months | |
Secondary | Humoral change after treatment (1) | Test the cytokine level using ELISA kit to evaluate the status before and after treatment • Four blood test sessions and saliva collection will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months | |
Secondary | Humoral change after treatment (2) | Test the hormone level using ELISA kit to evaluate the status before and after treatment • Four blood test sessions and saliva collection will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively. |
12 months | |
Secondary | Genetic variance | Genetic variants associated with baseline demographics and treatment response as assessed with genome-wide association study using the genotyping data derived from the Axiom Genome-wide array • Blood draw before the treatment to extract DNA for further sequencing |
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