5 Clinical Trials for Various Conditions
Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. The term "brain fatigue" is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant to examine if mental impairment is present in PPS patients and, if so, how it interferes on the self-function of patients. Patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. Patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. Through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.
This study, conducted at the Walter Reed Army Medical Center, the National Rehabilitation Hospital, and the National Institutes of Health, will examine whether the drug Modafinil can decrease fatigue in patients with post-polio syndrome. Many people who have had polio develop weakness and severe fatigue several years after their recovery from the acute disease. Modafinil is approved by the Food and Drug Administration to improve wakefulness in patients with narcolepsy (disease in which patients have excessive daytime sleepiness) and has been used to treat patients with fatigue related to other medical conditions, such as multiple sclerosis. This study will compare the effects of two doses of Modafinil and of a placebo (a pill with no active ingredient) on fatigue in patients with post-polio syndrome. Patients who develop fatigue, weakness, muscle pain or atrophy, and functional loss at least 15 years after recovering from polio and whose symptoms cannot be attributed to another cause may be eligible for this study. Candidates will be screened with a medical history, physical and neurological examinations, fatigue rating scales, electrocardiogram, blood and urine tests, drowsiness and depression evaluations, and an electroymogram (EMG) to diagnose nerve or muscle problems. For the EMG, electrodes (small metal discs) are taped to the skin and a needle is inserted into a muscle to record the electrical activity. Candidates will also undergo a sleep study to exclude abnormal sleep patterns as the cause of the fatigue. For this study, patients stay overnight at the NIH hospital. Electrodes are placed on the throat, on a finger, and on the chest (for an electrocardiogram), and a respiratory belt is placed around the chest-abdomen area. During sleep (from 10:30 p.m. to 6 a.m.), brain waves, eye and leg movements, muscle tone, respiration, and heart rate are recorded. Beginning at 8 a.m. the following morning, the patient takes 20-minute naps to measure the level of daytime sleepiness, using a recording technique similar to that of the all-night study. When five naps are completed, the sleep study ends. Candidates may also undergo a lumbar puncture (spinal tap) to check for certain chemicals in the spinal fluid that might be related to fatigue and to look for possible causes of post-polio syndrome. This procedure is optional. For the lumbar puncture, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Patients enrolled in the study will complete a sleep diary during the entire study period. They will be randomly assigned to one of two treatment groups-Modafinil or placebo-for 6 weeks, followed by a 2-week washout period with no medication, and then a crossover phase, in which patients who took Modafinil for the first 6 weeks now take placebo, and those who took placebo now take Modafinil. At the first study visit, patients will be given a supply of study medication and have blood drawn. They will take one pill twice a day during both study phases. In both study phases, evaluations will be done 3 and 6 weeks after starting the medication. The evaluations include filling out the same forms completed at the screening visit, a review of drug side effects, and a review of medical problems since the last study visit. At the 6-week visit, blood is also drawn.
Polio or poliomyelitis is the disease caused by the poliovirus. The virus attacks cells in the spinal cord and causes symptoms of fever, sore throat, headache, vomiting, and stiffness of the neck. Patients with polio can have long-term weakness of muscles as a result of the damaged cells in the spinal cord. Occasionally, patients that recover from the disease can experience a relapse of muscle weakness. This can occur as long as 25-35 years after first having polio. The condition is called "post-polio syndrome". Not all nerve cells in the spinal cord are damaged by the poliovirus. Some nerve cells remain healthy and take over the work of the damaged cells. Researchers believe that the "post-polio syndrome" may be caused by failure of these overworked nerve cells. However, what causes these overworked nerve cells to disintegrate is unknown. The purpose of this study is to apply specific scientific tests to answer important questions about the causes and development of the post-polio syndrome. Researchers will investigate possible genetic, immunologic, and physiologic causes of the "post-polio syndrome". The study itself will not provide therapy for patients with the condition, but may lead to the development of therapies in the future.
This study will investigate problems with muscle weakness and control using electromyography-a test of nerve-muscle cell communication. Advanced techniques called single fiber electromyography and macro-electromyography, which evaluate individual muscle fibers, will be used. Besides aiding in diagnosis, these tests provide information about disease progression that may be useful in guiding therapy. Adult patients with suspected neurological disorders of muscle control and weakness may be eligible for this study. Normal volunteers may also participate. For the electromyography procedure, a special needle is inserted into a muscle. The patient will slightly tense the muscle and maintain the tension while electrical signals from the muscle fibers are being recorded. The electrical signals are played through a loudspeaker, providing feedback to help the patient tense the muscle the appropriate amount. The test, which is usually done for only one muscle, takes 1 to 2 hours. If needed, short breaks can be taken. If the patient cannot maintain tension in the muscle for the entire test period, a nerve will be stimulated to activate the muscle. A thin needle is inserted near the nerve, and a series of small electrical shocks are given to activate a nerve fiber. The electromyography needle is inserted into the muscle to measure the response, as described above. A neurologist receiving specialized training in clinical neurophysiology will do the electromyography procedure under the direct supervision of an experienced neurologist.
OBJECTIVE: Many persons who survive poliomyelitis develop pain, weakness, and fatigue many decades later. It is not known why some persons develop this syndrome and others do not. One possibility is that polio caused subclinical damage to the motor cortex. Autopsies in some polio patients have found damage to the brainstem and motor cortex as well as to spinal motor neurons. Alternatively, polio may have spared the motor cortex, but the cortex reorganized in different ways to compensate for the loss of spinal motor neurons. This study will first assess the integrity of central motor pathways in polio survivors with and without postpolio syndrome. The second goal will be to investigate differences in the intracortical mechanisms for controlling muscles affected and unaffected by polio. STUDY POPULATION: 60 patients who survived polio in childhood. Only patients with an unequivocal history of polio will be referred to this study. Half of the patients will have the post-polio syndrome. 30 normal volunteers, aged 21-75. DESIGN: Patients will be screened at the collaborating institution, the Uniformed Services University of the Health Sciences, which will also perform sensory evoked potential testing and MRI. At NIH, motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold. Intracortical facilitation will be used to assess using paired-pulse magnetic stimulation. Two muscles will be tested in each patient, one affected by polio and one unaffected by polio. In the affected muscle, intracortical facilitation will be assessed again after exercises it until it fatigues. OUTCOME PARAMETERS: Cortical thresholds and central motor conduction times to all four limbs will be measured in patients and compared to normal subjects. The mean intracortical facilitation at rest will be compared in affected and unaffected muscles in polio patients with and without post-polio syndrome.