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Neurologic Signatures of Chronic Pain Disorders

This study is currently recruiting participants.
Verified March 2016 by Taipei Veterans General Hospital, Taiwan
Sponsor:
ClinicalTrials.gov Identifier:
NCT02747940
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Science and Technology, R.O.C.
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
  Purpose

"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.

Condition Intervention Phase
Chronic Pain Chronic Migraine Fibromyalgia Drug: flunarizine and/or pregabalin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurologic Signatures of Chronic Pain Disorders

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • clinical improvement after treatment (1) headache/pain intensity [NRS, numeric rating scale] [ Time Frame: 4 months ]
    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)

  • clinical improvement after treatment (2) headache/pain frequency [attacks per month] [ Time Frame: 4 months ]
    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)

  • clinical improvement after treatment (3) headache/pain duration [hours per day] [ Time Frame: 4 months ]
    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)


Secondary Outcome Measures:
  • EEG change after treatment [ Time Frame: 4 months ]

    Linear and nonlinear analysis of EEG before and after treatment

    • Three EEG session will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 2-month/4-month treatment course, respectively.
    • The EEG analyses include linear (eg: power spectrum, coherence, functional connectivity) analyses as well as non-linear (eg: entropy) analyses.

  • sensory and pain threshold change after treatment [ Time Frame: 2 months ]

    Using quantitative sensory testing (QST) to evaluate the sensory and pain threshold before and after treatment

    • Three QST session will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 2-month/4-month treatment course, respectively.
    • Equipment: electric von Fray filaments
    • unit: gram

  • Autonomic function change after treatment [ Time Frame: 2 months ]

    Using heart rate variability (HRV) to evaluate autonomic function before and after treatment

    • Three HRV session will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 2-month/4-month treatment course, respectively.
    • The HRV analyses include time-domain (eg: mean heart rate and its variation, mean R-R interval and its variation), and also frequency domain analysis (eg: power spectrum)


Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients with chronic migraine
flunarizine for patients with chronic migraine
Drug: flunarizine and/or pregabalin
Experimental: patients with fibromyalgia
pregabalin for patients with fibromyalgia
Drug: flunarizine and/or pregabalin
Experimental: patients with chronic migraine and fibromyalgia
flunarizine and pregabalin for patients with chronic migraine and myalgia
Drug: flunarizine and/or pregabalin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747940


Contacts
Contact: Wei-De Tsai +886-2-28712121 ext 3249 wilson12@seed.net.tw, wttsai2@vghtpe.gov.tw

Locations
Taiwan
Headache Center, Teipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Shuu-Jiun Wang, MD    +886-2-28712121 ext 2425    sjwang@vghtpe.gov.tw   
Contact: Jong-Ling Fuh, MD    +886-2-28712121 ext 3256    jlfuh@vghtpe.gov.tw   
Principal Investigator: Shuu-Jiun Wang, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Ministry of Science and Technology, R.O.C.
Investigators
Principal Investigator: Shuu-Jiun Wang, M.D. Neurological Institute, Taipei Veterans General Hospital
  More Information

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02747940     History of Changes
Other Study ID Numbers: 2015-10-001BC2015-11-001AC002B
First Submitted: April 1, 2016
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Chronic Pain
Fibromyalgia
Somatoform Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Mental Disorders
Pregabalin
Flunarizine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents