Ongoing projects

Trial of Sodium Oxybate. People with CFS often have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Sodium Oxybate (also known as Xyrem) is known to improve deep sleep and to improve symptoms in Fibromyalgia, an illness which is often seen with CFS. The purpose of this study is to determine if Sodium Oxybate reduces fatigue and other symptoms of CFS including muscle and joint achiness, unrefreshing sleep and cognitive complaints.

Subjects in this study are randomly assigned to one of two groups, Sodium Oxybate or Placebo. Subjects in the Sodium Oxybate group will receive the actual medication while those in the placebo group will receive a drug that looks identical to the real medicine but with no active ingredients. The two groups will allow the researcher to determine the effectiveness of the drug. Subjects will then be contacted weekly for a series of six weeks at which time they will be asked questions about their fatigue, sleepiness, difficulty with attention or concentration, achiness, and overall wellness. The dosage will also be increased weekly until the subject achieves good sleep or the maximum dose is reached.

Vagus Nerve Stimulation in Fibromyalgia Trial. Fibromyalgia Syndrome (FMS) is a chronic pain disorder of unknown origin, characterized by diffuse body pain and tenderness, often accompanied by depression and work disability. Conventional drug and behavioral therapies are often not successful in relieving FMS pain over time. For refractory FMS patients, those with severe, unrelenting pain, opioid maintenance therapy, the current 'last resort' treatment option, can be efficacious, however, it is commonly avoided for fear of addiction. Thus, FMS pain is often unrelieved leading to poor quality of life, disability, and economic disadvantage..

Based on the encouraging results of pre-clinical and clinical research studies suggesting that VNS therapy may target central nervous system (CNS) processes involved in pain transmission at both spinal and supraspinal levels,stimulation of the vagus nerve might reduce pain and improve quality of life. The vagus nerve begins in the brain; it affects the vocal cords, the acid content of the stomach, the heart, the lungs, and other organs. VNS may affect certain regions and chemicals in the brain in a way that may reduce pain symptoms associated with FM. Thus, we believe that VNS therapy could be a viable adjunctive treatment option for patients with refractory FMS. However, in order to proceed toward testing the efficacy of VNS therapy in refractory FMS patients, it is necessary to first determine its tolerability. .

Cyberonics, Inc. is the manufacturer of a device that permits long-term vagus nerve stimulation. In order to use this electrical device it needs to be surgically implanted below the collarbone in the same manner as is done with a cardiac pace maker. A wire from the stimulator is then wrapped around the left vagus nerve to allow the nerve to be stimulated. If an FMS patient were to participate, the patient would be in this VNS pilot study for at least one year.

The primary purpose of this pilot study is to determine whether compared to treatment resistant patients with epilepsy and depression, VNS device implantation, ramp-up of stimulation of the vagus nerve, and finally continued stimulation at fixed parameters is as safe and tolerable in a representative sample of patients with severe and unrelenting FMS who may also suffer from depression and can be work disabled.

If VNS therapy is well tolerated by patients with severe and unrelenting FMS, the secondary purpose of this pilot study is to determine the impact of VNS therapy on symptoms of FMS including pain, physical function, mood, as well as quality of life.

Recruitment for the study is closed.

Computerized EMA Study. CFS patients have the major complaint that symptoms get worse following exertion and little objective evidence to help them understand why these symptoms exist. A major tactic for evaluating these symptoms has been the use of paper-and-pencil diaries to evaluate the daily pattern of CFS symptoms. However, problems exist using these vehicles because people often forget to record their symptoms throughout the day, and try to "catch up" later by recording symptoms at times other than those scheduled. This can lead to inaccurate and even false results. Recently, computerized electronic diaries were developed for ecological momentary assessment (EMA). Using EMA, we can ask a patient how he/she feels in real time, periodically throughout the day. The patient can answer our questions by responding on a small computer device that is worn like a watch. This device can collect and log data on subjective symptoms, cognitive function, and activity. We use the device to track symptoms before and after CFS patients perform an exercise test. How to get involved

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