Brain Rhythms in Fibromyalgia: A Magnetoencephalography (MEG) Study

NCT02159300 | Completed

• 1 other identifier: WS697348
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The long-term purpose of the investigator's research is to understand the pathophysiological basis of chronic pain. This will help provide a framework for the development of effective treatments. The purpose of this specific study is to find if there are abnormal brain rhythms in patients with fibromyalgia syndrome (FM) who are in pain since this will indicate particular types of treatments. FM is a disorder of the muscles and/or joints, and patients experience sever fatigue. FM occurs more often in women than in men (3.4% of women, 0.5% of men). The diseases can appear at any age, but in most of the cases it occurs in women of childbearing age. FM is considered a chronic pain condition since the pain is persistent. Pain and tenderness can be widespread throughout the body. FM patients are more sensitive to sound and pressure stimulation than healthy controls, indicating that there may be changes in the brain. Also, pain is made worse under conditions of stress. Treatments for FM pain include life style changes such as exercise, dietary changes, cognitive-behavioral therapy, medications and even surgery, but there is no accepted "best" treatment. This is partly because the underlying cause of the pain is not well understood. The design of this study is to record brain activity to find if there are abnormal brain rhythms in people with FM that are not present in healthy adults of the same age. Specifically, the investigators will test the hypothesis that constant low frequency oscillations will be present in patients with chronic pain due to FM. This has been found in people with other types of pain and is called Thalamocortical Dysrhythmia (TCD). The study has two parts. In the first part, a complete medical history will be obtained, including a description of the person's pain. In the second part the investigators will use magnetoencephalography (MEG) to non-invasively record brain activity. The MEG data will be analyzed in terms the presence of normal alpha rhythm and abnormal low and high frequency oscillations. Each person will have an MRI so the investigators can localize the rhythms recorded by the MEG in the person's brain using their MRI. The people who record and analyze the MEG recordings will not know if the person is a healthy control or a FM patient. The two parts will be joined to test the hypothesis and find if there is a correlation between the people with abnormal low frequency brain rhythms and the presence or degree of pain.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pain

Outcome Measures

Primary Outcomes (1)

• Spectral Power of brain magnetic activity

  The power of brain activity in the delta, theta, alpha, beta and gamma frequency ranges.

  Expected average of one week after MEG recoring

Secondary Outcomes (1)

• Brain location of electromagnetic sources of activity

  Expected average of one month after MRI

Other Outcomes (1)

• Pain scores on the Visual Analogue Scale

  At time of magnetic recording

Study Arms (2)

Patients

Patients with fibromyalgia pain Intervention: experience brain activity recording

Behavioral: experience brain activity recording

Healthy Controls

Healthy controls without chronic pain of any type.

Behavioral: experience brain activity recording

Interventions

experience brain activity recording BEHAVIORAL

Intervention: experience brain activity recording

Also known as: Change in pain level

Healthy Controls; Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with fibromyalgia pain in the greater New York City area. Pain-free women in the greater New York City area.

You may qualify if:

• female from any racial/ethnic background
• general good health, with no serious or unstable medical conditions
• normal or corrected-to-normal vision and hearing
• meets the American College of Rheumatology criteria for the diagnosis of fibromyalgia for at least 1 year
• has had continued presence of pain for more than 50% of the last month
• a score of \>1 on the unidimensional 100-cm visual analog scale (VAS) for pain level
• has been on a stable medication regimen for at least 3 weeks, with no change greater than +/- 20% variation on total daily dosage
• years of age
• is right handed
• willing to complete all study procedures
• is capable of giving written informed consent

You may not qualify if:

• in-patient
• a history of brain abnormalities such as stroke, ventriculomegaly or periventricular white matter abnormalities
• has not been on a stable medication regimen for at least 3 weeks, with any change greater than +/- 20% variation on medication total daily dosage
• has a history of substance abuse
• has the presence of concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain
• has concurrent participation in other therapeutic trials
• pregnant and nursing mothers
• has severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years)
• or has current major depression. \[Depression in these patients will be assessed with the Hospital Anxiety and Depression Scale (HADS). Categorization of fibromyalgia patients with high depressive symptoms is defined as \>8 for the HADS
• has contraindications for MRI scanning or MEG recording, including any of the following: cardiac pacemaker, intracranial clips, metal implants, or external clips within 10 mm of the head, metal in eyes, claustrophobia, obesity and/or any other reason leading to difficulty getting in the MEG chair or laying supine in the MRI magnet for up to one hour
• Existence of any other chronic pain conditions, in addition to fibromyalgia

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Center for the Study & Treatment of Pain

New York, New York, 10016, United States

Location

NYU School of Medicine; Center for Neuromagnetism

New York, New York, 10016, United States

Location

Related Publications (10)

• Burgmer M, Pogatzki-Zahn E, Gaubitz M, Stuber C, Wessoleck E, Heuft G, Pfleiderer B. Fibromyalgia unique temporal brain activation during experimental pain: a controlled fMRI Study. J Neural Transm (Vienna). 2010 Jan;117(1):123-31. doi: 10.1007/s00702-009-0339-1. Epub 2009 Nov 25.

  PMID: 19937376 BACKGROUND

• Dale AM, Fischl B, Sereno MI. Cortical surface-based analysis. I. Segmentation and surface reconstruction. Neuroimage. 1999 Feb;9(2):179-94. doi: 10.1006/nimg.1998.0395.

  PMID: 9931268 BACKGROUND

• Jeanmonod D, Magnin M, Morel A. Thalamus and neurogenic pain: physiological, anatomical and clinical data. Neuroreport. 1993 May;4(5):475-8. doi: 10.1097/00001756-199305000-00003.

  PMID: 8513122 BACKGROUND

• Llinas RR, Ribary U, Jeanmonod D, Kronberg E, Mitra PP. Thalamocortical dysrhythmia: A neurological and neuropsychiatric syndrome characterized by magnetoencephalography. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15222-7. doi: 10.1073/pnas.96.26.15222.

  PMID: 10611366 BACKGROUND

• Makela JP, Forss N, Jaaskelainen J, Kirveskari E, Korvenoja A, Paetau R. Magnetoencephalography in neurosurgery. Neurosurgery. 2007 Jul;61(1 Suppl):147-64; discussion 164-5. doi: 10.1227/01.neu.0000279212.23010.82.

  PMID: 18813173 BACKGROUND

• McCubbin J, Vrba J, Spear P, McKenzie D, Willis R, Loewen R, Robinson SE, Fife AA. Advanced electronics for the CTF MEG system. Neurol Clin Neurophysiol. 2004 Nov 30;2004:69.

  PMID: 16012695 BACKGROUND

• Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.

  PMID: 20506181 BACKGROUND

• Shiraishi H, Ahlfors SP, Stufflebeam SM, Takano K, Okajima M, Knake S, Hatanaka K, Kohsaka S, Saitoh S, Dale AM, Halgren E. Application of magnetoencephalography in epilepsy patients with widespread spike or slow-wave activity. Epilepsia. 2005 Aug;46(8):1264-72. doi: 10.1111/j.1528-1167.2005.65504.x.

  PMID: 16060938 BACKGROUND

• Walton KD, Dubois M, Llinas RR. Abnormal thalamocortical activity in patients with Complex Regional Pain Syndrome (CRPS) type I. Pain. 2010 Jul;150(1):41-51. doi: 10.1016/j.pain.2010.02.023. Epub 2010 Mar 24.

  PMID: 20338687 BACKGROUND

• Weinberg H, Brickett PA, Vrba J, Fife AA, Burbank MB. The use of a squid third order spatial gradiometer to measure magnetic fields of the brain. Ann N Y Acad Sci. 1984;425:743-52. doi: 10.1111/j.1749-6632.1984.tb23597.x.

  PMID: 6331246 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodolfo R Llinas, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 9, 2014
• Study Start: December 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (2)