Neurologic Signatures of Chronic Pain Disorders
1 other identifier
interventional
200
1 country
1
Brief Summary
"Brain signatures" as objective measures of acute pain have been characterized with functional magnetic resonance image and machine learning technology. As compared to acute pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain remain subjective and suboptimal, and the brain signatures for chronic pain are largely unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders with high disability and intractability with prevalence of around 2% for both diseases. These two chronic pain disorders have shared clinical presentations (abnormal pain sensitivity, mood and sleep disorders), pathophysiology (central sensitization) and medical treatment (anti-depressants), despite different body parts are involved (head vs. whole body). The present integrated project aims to characterize both common and disease-specific brain signatures of chronic pain by investigating these two chronic pain disorders. Our findings may shed some light on the key mechanisms of pain chronification, and may pave the way for the optimization of diagnosis and prognostication, as well as formulation of personalized medicine in chronic pain, so as to improve life quality of these patients and to reduce socioeconomic loss. The present project includes three interdisciplinary sub-projects (plus one animal study, not listed here): A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis of brain connectomes C. Data stream mining technology for multimodal physiological signals of chronic pain: real-time tracking and clinical correlation The specific aims of the present projects include:
- 1.Identification of common and disease-specific brain signatures for chronic pain (sub-projects A, B, C)
- 2.Investigation of clinical indicators with predictive values by machine learning analysis of big data (sub-projects A, B, C)
- 3.Elucidation of the specific anatomical structures or neural networks underpinning pain chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year pilot study of the 4-year longitudinal study, we will establish experimental platforms for each sub-project, start to recruit participants and perform endophenotyping, as well as have a preliminary integration for sub-projects A, B and C.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedNovember 2, 2020
October 1, 2020
4 years
April 1, 2016
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
clinical improvement after treatment (1) headache/pain intensity [NRS, numeric rating scale]
clinical improvement (headache/pain intensity) after treatment unit: NRS (numeric rating scale, 0-10) analysis: comparing the mean headache/pain intensity in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)
4 months
clinical improvement after treatment (2) headache/pain frequency [attacks per month]
clinical improvement (headache/pain frequency) after treatment unit: attacks per month analysis: comparing the mean headache/pain frequency in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)
4 months
clinical improvement after treatment (3) headache/pain duration [hours per day]
clinical improvement (headache/pain duration) after treatment unit: hours/day analysis: comparing the mean headache/pain duration (hours/day) in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)
4 months
Secondary Outcomes (3)
EEG change after treatment
4 months
sensory and pain threshold change after treatment
2 months
Autonomic function change after treatment
2 months
Study Arms (3)
patients with chronic migraine
EXPERIMENTALflunarizine for patients with chronic migraine
patients with fibromyalgia
EXPERIMENTALpregabalin for patients with fibromyalgia
patients with chronic migraine and fibromyalgia
EXPERIMENTALflunarizine and pregabalin for patients with chronic migraine and myalgia
Interventions
Eligibility Criteria
You may qualify if:
- Control: devoid of any systemic or neurological diseases
- Chronic migraine: by ICHD-III (International Classification of Headache Disorder) criteria
- Fibromyalgia: by ACR (American College of Rheumatology) 2010 criteria
You may not qualify if:
- history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
- history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
- history of substance abuse (except painkillers)
- heavy smokers (with a daily consumption \>20 cigarettes)
- pregnancy or lactation
- any contraindication for magnetic resonance imaging (MRI)
- and any obvious infection or inflammation over a period of at least 1 month before the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Headache Center, Teipei Veterans General Hospital
Taipei, 112, Taiwan
Related Publications (5)
Chuang CH, Li JY, King JT, Chen WT, Chen SP, Wang YF, Liu HY, Hsiao FJ, Pan LH, Wang SJ, Lai KL. Abnormal heart rate variability and its application in predicting treatment efficacy in patients with chronic migraine: An exploratory study. Cephalalgia. 2023 Oct;43(10):3331024231206781. doi: 10.1177/03331024231206781.
PMID: 37851663DERIVEDPan LH, Chen WT, Wang YF, Chen SP, Lai KL, Liu HY, Hsiao FJ, Wang SJ. Resting-state occipital alpha power is associated with treatment outcome in patients with chronic migraine. Pain. 2022 Jul 1;163(7):1324-1334. doi: 10.1097/j.pain.0000000000002516. Epub 2021 Oct 13.
PMID: 35708466DERIVEDPan LH, Wang YF, Ling YH, Lai KL, Chen SP, Chen WT, Treede RD, Wang SJ. Pain sensitivities predict prophylactic treatment outcomes of flunarizine in chronic migraine patients: A prospective study. Cephalalgia. 2022 Aug;42(9):899-909. doi: 10.1177/03331024221080572. Epub 2022 Apr 11.
PMID: 35400174DERIVEDHsiao FJ, Chen WT, Liu HY, Wang YF, Chen SP, Lai KL, Hope Pan LL, Coppola G, Wang SJ. Migraine chronification is associated with beta-band connectivity within the pain-related cortical regions: a magnetoencephalographic study. Pain. 2021 Oct 1;162(10):2590-2598. doi: 10.1097/j.pain.0000000000002255.
PMID: 34534180DERIVEDHsiao FJ, Chen WT, Ko YC, Liu HY, Wang YF, Chen SP, Lai KL, Lin HY, Coppola G, Wang SJ. Neuromagnetic Amygdala Response to Pain-Related Fear as a Brain Signature of Fibromyalgia. Pain Ther. 2020 Dec;9(2):765-781. doi: 10.1007/s40122-020-00206-z. Epub 2020 Oct 22.
PMID: 33090368DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuu-Jiun Wang, M.D.
Neurological Institute, Taipei Veterans General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2016
First Posted
April 22, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2019
Last Updated
November 2, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share