Understanding pain sensitivity in migraine using brain imaging techniques

Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature

This study is testing how brain activity related to pain sensitivity works in people with migraines compared to those without, to help find better treatments for migraine relief.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Taipei Veterans General Hospital, Taiwan (Government)
• Locations: 1 site (Taipei)
• Trial ID: NCT04702971 on ClinicalTrials.gov

What this trial studies

This study aims to explore the underlying mechanisms of pain sensitivity in individuals suffering from migraines by utilizing advanced neuroimaging techniques to analyze brainstem activity. Participants will include both migraine sufferers and healthy controls, allowing for a comparative analysis of brain function. The research focuses on deep phenotyping to better understand the dysregulated pain modulatory networks in the brainstem, which are believed to contribute to migraine symptoms. By identifying these mechanisms, the study seeks to pave the way for novel treatment strategies for migraine management.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 20-65 who meet the diagnostic criteria for migraine and experience at least four headache days per month.

Not a fit: Patients with a history of epilepsy, severe psychological disorders, or those currently taking migraine prophylactics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for migraine sufferers by enhancing the understanding of pain mechanisms.

How similar studies have performed: While there have been studies focusing on migraine treatment, this approach utilizing deep brain imaging techniques is relatively novel and has not been extensively tested.

Eligibility criteria

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)

Where this trial is running

Taipei

• Headache Center, Teipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Shuu-Jiun Wang

Conditions Migraine