NEW YORK (March 7, 2013) -- Weill Cornell Medical College has been awarded more than $1.9 million by the National Institute of Mental Health of the National Institutes of Health to lead an innovative research study using advanced neuroimaging and clinical evaluations of patients with chronic fatigue syndrome (CFS). The new four-year clinical study, to be conducted in collaboration with Icahn School of Medicine at Mount Sinai and Beth Israel Medical Center, will aim to expand the scientific understanding of CFS, improve diagnostics for the condition and discover novel biomarkers, all of which may lead to the identification of new and more effective treatment targets.
"Research funding for chronic fatigue syndrome has been historically limited," says principal investigator Dr. Dikoma Shungu, professor of physics in radiology and chief of the Laboratory for Advanced Magnetic Resonance Spectroscopy Research at Weill Cornell Medical College. "This large, generous NIH grant award will allow us to accelerate in-depth, novel clinical research for CFS to make the significant strides we vitally need for research discovery and clinical care."
The new multidisciplinary clinical research study will be headquartered at Weill Cornell in Dr. Shungu's laboratory at Weill Cornell's Citigroup Biomedical Imaging Center using advanced magnetic resonance spectroscopy neuroimaging technology, including its 3.0 T MRI scanner. Clinical research and assessments will also be conducted at Mount Sinai's Mood and Anxiety Disorders Program and through the Pain & Fatigue Study Center at Beth Israel Medical Center.
CFS is a difficult to diagnose and complex, multi-system disorder. It is considered a medically mysterious illness and is often misdiagnosed. Differentiation of CFS and neuropsychiatric illnesses, such as major depressive disorder (MDD), can be daunting and is a continuing challenge.
Symptoms of CFS include severe, debilitating and lasting fatigue that is not alleviated by rest and may be accompanied by a constellation of symptoms, including musculoskeletal pain, sore throat, headaches, impaired concentration, short-term memory and sleep disturbances. A characteristic feature of CFS is post-exertional relapse, a recurrence or worsening of symptoms after even minor physical or mental activity. Its clinical presentation, combined with the lack of current validated diagnostic tests and its overlap of symptoms with disorders like MDD, can make CFS difficult to diagnose.
This NIH supported clinical research study will build upon the last seven years of research conducted by the partnering institutions Weill Cornell, Mount Sinai and Beth Israel. In recent small pilot clinical studies, generously supported by The CFIDS Association of America, these three academic medical research centers have investigated CFS using sophisticated neuroimaging and battery of clinical tests. Their preliminary, small pilot study findings show the key culprit in CFS may be increased and sustained oxidative stress evidenced in the neuroimaging scans, blood and bodily fluid tests of CFS patients. Specifically, their research shows levels of cortical glutathione (GSH) -- the most abundant and one of the most important antioxidants in living tissue -- are decreased by 36 percent in CFS patients. This novel cortical GSH deficit finding was also correlated with those patients with increased levels of blood markers of oxidative stress and symptoms of CFS. Study results also show CFS patients also have significantly elevated ventricular cerebrospinal fluid (CSF) lactate and decreased regional cerebral blood flow (rCBF).
"Our initial studies implicate oxidative stress as a key factor in the pathophysiology of CFS," says Dr. Shungu. "We look forward to investigating further our highly promising and consistent findings in an expanded study thanks to NIH support. This new study will help give validity and the specificity of our oxidative stress hypothesis, and we aim to find promising therapeutic targets and novel treatments for patients."
However, researchers found in their pilot studies that the abnormalities identified in CFS patients are similar to the abnormalities witnessed in MDD patients. In the new study, researchers hope to decode CFS and distinguish it from neuropsychiatric conditions such as MDD. This current uncertainty makes it critical for research studies to investigate the nature of comorbidity in CFS.
"The discovery of specific biomarkers that can differentiate CFS from similarly presenting psychiatric disorders will have a profound impact for how the disorder is perceived, managed, diagnosed and for the development of objective diagnostic tests, therapeutic targets and advanced scientific understanding of this mysterious debilitating illness," says Dr. Shungu.
Researchers believe this study is highly innovative, representing a departure from nearly all previous studies for CFS to date. They trust it may be the first comprehensive attempt to identify brain biomarkers for the condition.
"This new CFS research will help show distinct medical patterns in CFS patients helping to drive discovery of more efficient diagnostics and treatments, ultimately improving the health and quality of life of patients," says K. Kim McCleary, president & CEO of The CFIDS Association of America. "This tremendous $2 million in NIH support validates the need for more research and new treatments for this chronic illness that typically suddenly hits patients like a tornado. We hope this study closes the scientific gap for the disorder so we can halt this debilitating condition in its tracks, finally restoring hope for patients and their families battling CFS."
Other study investigators include Dr. Benjamin Natelson of Beth Israel and Dr. Dan Iosifescu of Mount Sinai. For this study, Weill Cornell, Mount Sinai and Beth Israel plan to enroll 40 patients with CFS, 40 MDD patients and 20 healthy controls. To learn more about enrolling in the study, call 212-746-2632.
Thanks to previous CFIDS Association of America research funding, Weill Cornell and its research partners were able to secure the preliminary study data necessary to be awarded this NIH grant award. This research is supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R01MH100005.
Weill Cornell Medical College
Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances -- including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston. For more information, visit weill.cornell.edu.
The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai. Established in 1968, the Icahn School of Medicine at Mount Sinai is one of the leading medical schools in the United States. The Icahn School of Medicine is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty members in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report. The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation's oldest, largest and most-respected voluntary hospitals. In 2012, U.S. News & World Report ranked The Mount Sinai Hospital 14th on its elite Honor Roll of the nation's top hospitals based on reputation, safety, and other patient-care factors. Mount Sinai is one of just 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and by U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.
Beth Israel Medical Center
Beth Israel Medical Center, a licensed,1,106-bed, tertiary care, teaching hospital, serves as University Hospital and the Manhattan Campus of the Albert Einstein College of Medicine. Founded on Manhattan's Lower East Side in 1889, Beth Israel provides inpatient care through two major divisions: The Milton and Carroll Petrie Division in Lower Manhattan and Beth Israel Brooklyn in the Midwood section of Brooklyn, as well as through a network of outpatient and ambulatory facilities, primary and specialty care practices and unique physician partnerships. It is notable for its unique approach in combining medical excellence with clinical innovation. Beth Israel's world-class specialists have helped to expand the Medical Center's services in heart disease, cancer, neurology, orthopedics, and pain medicine and palliative care, among others. At the same time, the Medical Center has forged links between conventional medicine and integrative approaches to care through the Continuum Center for Health & Healing. Beth Israel also continues its long tradition of excellence in medical specialties including gastrointestinal disease, chemical dependency, psychiatric disorders and HIV/AIDS research and treatment.
The CFIDS Association of America
The Association's mission is to make CFS widely understood, diagnosable, curable and preventable. Our strategy is to stimulate research aimed at the early detection, objective diagnosis and effective treatment of CFS through expanded public, private and commercial investment. Second only to the federal government in funding initiatives for CFS, since 1987 the Association has invested $32 million in initiatives to end the life-altering disability, stigma and isolation of CFS. For information and resources for patients, family members, caregivers, support groups, media professionals, the general public and health care professionals, visit www.research1st.org or www.cfids.org.