9 Clinical Trials for Various Conditions
Dementia refers to a condition where there is a loss of intellectual function (cognition). It is usually a progressive condition that interferes with normal social and occupational activities. Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in personality, such as aggressiveness, agitation, and depression. In addition, patients with FLD may have difficulty planning tasks and may have a loss of motivation. Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is used by neurons to communicate with other neurons. Researchers are inclined to believe that by replacing the missing serotonin, symptoms of FLD may be relieved. Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the body. They have been used successfully to treat patients with depression and patients with violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively easy to give (once daily), is safer than most other serotonin reuptake blockers (very little effect on vital enzyme systems \[cytochrome P-450\]), and has few interactions with other drugs. This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks and a placebo "inactive sugar pill" for 6 weeks. During the study, researchers will test psychological and neurological functions to measure the effects of the drug.
The Cognitive Neuroscience Section of the National Institute of Neurological Disorders and Stroke proposes to continue its cross-sectional and longitudinal studies of cerebral metabolism in frontal lobe dementias and atypical basal ganglia disorders. These studies include repeated assessments of neuropsychological and brain anatomical and metabolic function in subjects with these important and possibly related brain disorders.
The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia. The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia. The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight
This study will examine the underlying mental processes that determine how people understand social behavior, remember information, and think. Language, planning, problem solving, reasoning, social behavior, and memory are the critical parts of cognition that make up daily life. This study will explore the association between performance on various experimental tasks and day-to-day functioning. Healthy normal volunteers and patients with certain kinds of brain damage (primarily focal or degenerative lesions of the human prefrontal cortex) or psychiatric disorders may be eligible for this study. Candidates with central nervous system trauma, disease or dysfunction will be screened with a routine neurological examination and history. Participants may be asked to complete written tests, sit in front of a computer monitor and press a key to indicate a decision about what appears on the screen (for example, whether a statement is accurate) and answer questions from a test examiner. A skin conductance response (SCR) test may be done along with some of the cognitive tests. SCR uses electrodes (pieces of metal attached to wires) placed on the fingers to measure the subject's emotional reaction to a test. Participants may also do an evoked response test, in which the subject watches words or scenes on a TV screen while his or her responses are recorded from electrodes placed on the scalp (similar to an electroencephalogram). The tests will be scheduled for an average of one session a week, with each session lasting from 30 minutes to 3 hours. Generally, 15 sessions will be scheduled over a 1-year period. Special arrangements will be made to accommodate participants from out-of-town. Participants may have a magnetic resonance imaging (MRI) scan of the brain. This test uses radio waves and a strong magnetic field to picture structural and chemical changes in tissue. For the procedure, the subject lies on a table in a space enclosed by a metal cylinder (the scanner) for about 1 hour. In addition, some study subjects will be invited to participate in a training study designed to improve their planning or social behavior. Participation requires coming to NIH daily over a 1- to 2-month period for 1 to 2 hours each visit.
Imaging studies of the brain have revealed the different areas involved in the processes of learning and reasoning. However, the specific role these regions play in these processes, or if stimulating these areas can improve these processes is unknown. Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand the roles of individual brain regions on the processes of learning and reasoning. Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses. The purpose of this study is to use rTMS to help determine the roles of different brain regions in the development of implicit learning of motor sequences and analogic reasoning. In addition, researchers hope to evaluate if stimulation of these regions speeds up the process of learning or analogic reasoning.
This pilot study will evaluate the effect of direct current (DC) electrical polarization of the brain on language, memory, reaction time, and mood in six patients with frontotemporal dementia (Pick's disease). There is no effective treatment available for cognitive impairment in patients with this condition. DC polarization sends a very weak current between two sponge pads placed on the head. In a previous study in healthy volunteers, DC polarization of the left prefrontal area of the brain increased verbal fluency, memory and attention, and motor reaction time in the study subjects. Patients between 35 and 75 years of age with frontotemporal dementia who have been referred to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered participation in this study. Candidates will be screened with a neurological examination to confirm the diagnosis of frontotemporal dementia. Participants receive 40 minutes of DC polarization or sham polarization in each of two separate sessions. (No current is applied in the sham treatment). During the polarization, the patient rests quietly. Sponge pads that have been soaked in water are put on the left side of the head and above the right eye, and are held in place with elastic netting. Before the polarization and after about 20 minutes of polarization, patients undergo the following tests: * Language: Patients must say as many words beginning with certain letters as they can in 90 seconds. * Memory: Patients must remember a letter on a computer screen, and when the letter appears again, press the same letter on the keyboard. * Reaction time: Patients place pegs on a pegboard. * Mood: Patients place a mark on a line ranking how they feel.
This project is designed to test how direct current (DC) electrical polarization of the brain affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the second most common form of dementia after Alzheimer's disease. It causes profound disturbances of language and other cognitive functions and often results in highly disruptive behavior. There is no effective treatment for the behavioral disorder or cognitive deficits in FTD. In an earlier study, the researchers used DC polarization to the primary motor cortex to enhance prefrontal function in healthy subjects. The experiment resulted in greater verbal fluency. In a separate study of five patients with FTD, a similar effect on verbal fluency was produced. The object of the current study is to replicate these findings in a larger group of patients and to see if the results carry over into "real world" behavior. Participants will be 20 patients aged 35 to 75 years with FTD, referred to the Cognitive Neuroscience Section. Participants will be tested in two sessions, separated by at least 48 hours. In one session they will receive 40 minutes of anodal DC polarization; in the other they will receive 40 minutes of sham polarization. Participants will be tested for language, memory, and reaction time before and 20 minutes after the polarization. For the behavior portion of the study, the Neuropsychiatric Inventory will be completed by an investigator with the caretaker on admission (covering the preceding week) and again, by telephone, 1 week after discharge, to cover the first week home. Participants will receive no lasting benefit as a result of the study, but the study is likely to yield generalizable knowledge on the effects of DC polarization treatment in FTD.
This study will test the effect of direct current (DC) brain polarization (the application of a very weak electrical current to the brain) on learning and memory. Earlier studies have shown that DC polarization can temporarily improve the ability of healthy people to think of certain words. This study will explore whether it can also temporarily improve learning and memory. Healthy people 18 years of age and older may be eligible for this study. Subjects participate in two experimental sessions at the NIH Clinical Center. The first session lasts about 1 hour; the second session, on the next day, takes about 10 minutes. At the beginning of the first session, electrodes are placed on the subject's head and arm for brain stimulation. The current may be turned on for 25 minutes, or only very briefly (sham stimulation). Subjects are not told which type of stimulation they are receiving. No stimulation is applied in the second session. During the sessions subjects are asked to complete the following tasks that will help elucidate the effects of polarization: * Read a list of words and remember them. Later they will try to repeat the words from memory. * Look at a series of designs and remember them. Later they will try to draw the designs from memory. * Push a button on a keyboard when they see a specific item (for example, when the number 7 appears). * Generate as many words as they can think of that begin with a particular letter of the alphabet. Subjects may be videotaped for some or all of the time during the sessions.
This study will examine the effects of direct current (DC) electrical polarization of the brain on thinking speed, reaction time, mood, and brain waves in healthy individuals. The results will provide information for designing further studies to examine the safety and effectiveness of this technique in treating certain brain diseases involving impaired cognition (thought processing). The study consists of three experiments; participants will take part in either one or two of the experiments. Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of education may be eligible for this study. Candidates will be screened with a medical and educational history and a brief neurological examination. Participants in experiments 2 and 3 will also be screened with a verbal fluency test in which they will be asked to say as many words beginning with certain letters as they can in 1 minute. Participants will undergo the following procedures for the experiment(s) in which they participate: Experiment 1 While resting quietly, subjects receive 20 minutes of weak electrical current stimulation or sham stimulation with no current. For the stimulation, two gauze pads soaked with a conducting salt solution are placed on the head-one on the left side and one above the right eye. The current is passed between the pads and may cause an itching or tingling sensation under the electrodes. Before and after the stimulation, the participant's reaction time-tested by moving a finger as fast as possible at the sound of a tone-and mood are evaluated. Some participants also have an electroencephalogram, or EEG (brain wave recording) during the experiment. After the stimulation, participants take two brief tests of thinking speed, and the mood and reaction time tests are repeated. Experiment 2 The participant sits in a chair with electrodes attached to the muscles that control movement in a finger on the right hand. Reaction time is tested as described in experiment 1. Then, transcranial magnetic stimulation (TMS) is used to test the activity of the brain's motor cortex (the part of the brain that controls movement). For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex. The stimulation may cause twitching of the right hand or arm or produce a mild snapping sensation on the scalp. During the stimulation, the electrical activity of muscles in the right hand is recorded on a computer. Following the TMS, DC stimulation is applied, as described in experiment 1. The stimulation begins at a low level and is followed by repeat TMS and DC stimulation at increasingly higher levels. This continues until there is a clear effect on the muscle response to the magnetic pulses, or until the stimulation becomes uncomfortable. At the end of the electrical stimulation, reaction time is tested again. Experiment 3 This experiment uses the average DC level that produced a change in the size of the responses to magnetic stimulation in experiment 2. Thinking speed and reaction time are tested during the DC stimulation, and the mood test is given before and during the stimulation. This test does not use TMS or EEG recording.