CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
flunarizine and/or pregabalindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02747940
NCT02747940Phase 4Completed

Neurologic Signatures of Chronic Pain Disorders

Taipei Veterans General Hospital, Taiwan·interventional·Posted Apr 22, 2016·Updated Nov 2, 2020

In Brief

A Phase 4 clinical trial evaluating flunarizine and/or pregabalin for Chronic Pain and 2 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 22, 2016
Enrollment StartDec 1, 2015
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.2 years ago

Interventions

flunarizine and/or pregabalindrug