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Epilepsy clinical trials

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NCT ID: NCT00085683 Completed - Epilepsy Clinical Trials

Herpes Virus-6 and Epilepsy

Start date: June 2004
Phase: N/A
Study type: Observational

This study will explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients. The virus is also thought possibly to interfere with neurotransmitters - chemicals that brain cells use to communicate with each other. This study will measure levels of two of these chemicals, GABA and glutamate, which are believed to play a role in the development of seizures. Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control subjects 18 years of age and older may be eligible for this study. Control subjects may not be taking any medication on a regular basis. Epilepsy patients may take only phenytoin, carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a physical examination and blood tests. Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar puncture (spinal tap). Blood Draw Up to four teaspoons of blood are drawn through a needle in the arm for this study. MRI MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which time the subject can communicate with the technician. Lumbar Puncture For this test the subject sits upright or lies on his or her side with knees curled at the chest. A local anesthetic is injected at the lower back, and a needle is inserted in the space between the bones where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Collection of the fluid usually takes from 5 to 20 minutes.

NCT ID: NCT00081432 Completed - Epilepsy Clinical Trials

Language and Emotional Function in Patients With Temporal Lobe Epilepsy

Start date: April 9, 2004
Phase: N/A
Study type: Observational

This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) to examine how the brain processes tasks involving language and emotion in normal volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies on a table that can slide in and out of the cylinder. DTI involves taking pictures of the brain while the subject is at rest in order to learn about the structure of the brain. Information gained from this study will help scientists evaluate the organization of language and emotional functions in the brain. Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are native English speakers and who will undergo surgery for uncontrolled seizures may be eligible for this study. Candidates are initially screened by telephone, then with physical and neurologic examinations and cognitive testing. The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled before surgery and Part 2 after surgery. - fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one task, they are shown pictures of animals and tools and are asked to name them. In a second task, they are shown pictures that range in content from sexually explicit material, to human injury and surgical slides, to pleasant images of children and wildlife and are asked to decide whether they find the pictures pleasant, neutral, or unpleasant. - DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes. - Neuropsychological testing: Subjects may be asked to complete questionnaires, take pen-and-paper or computerized tests, and perform motor tasks. Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up to four times to investigate different brain functions or to confirm findings.

NCT ID: NCT00079781 Completed - Epilepsy Clinical Trials

RNS® System Feasibility Study

Start date: January 2004
Phase: Phase 2
Study type: Interventional

The RNS® System is intended to treat patients with medically refractory (hard to treat) epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support the commencement of a pivotal clinical investigation.

NCT ID: NCT00072813 Completed - Epilepsies, Partial Clinical Trials

MRI in Autosomal Dominant Partial Epilepsy With Auditory Features

Start date: November 10, 2003
Phase: N/A
Study type: Observational

This study will examine the possible structural and functional abnormalities in patients with an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled epilepsy is a serious neurological problem with major harmful medical, social, and psychological effects, as well as greater mortality compared with the general population. The cost per year in the United States is at least $12.5 billion. There have been advances in diagnosing the disease, but the cause cannot be determined in many cases. Recently, several seizure syndromes found in families have been described. One syndrome of particular interest involves the lateral temporal lobe of the brain and often includes auditory features. Patients with that kind of syndrome may hear monotonous unformed sounds, but sometimes they may hear complex sounds, such as a song. Patients are eligible for this study if they have a specific form of familial epilepsy that is being studied at Columbia University in New York. Family members without seizures are eligible as well. All the patients in the study will be evaluated at Columbia before participating. Healthy volunteers aged 18 to 55 also may be eligible for this study. Participants will undergo a medical history and physical examination. During the study, they may have three or four sessions of MRI. During the MRI, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle the sound. Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI (fMRI) is done while patients are performing tasks, such as moving a limb or speaking. Patients will have an opportunity to practice such tasks before entering the scanner. The fMRI will take about 1 hour.

NCT ID: NCT00071370 Completed - Epilepsy Clinical Trials

Activating Effects of Sleep Deprivation on Synchronized MEG-EEG Recordings of Epilepsy Patients With Non-Diagnostic EEG

Start date: October 2003
Phase: N/A
Study type: Observational

This study will evaluate how the state of being completely deprived of sleep has an effect on recordings of magnetoencephalography (MEG) and electroencephalography (EEG), in relation to how alert someone is and how sleepy someone perceives himself or herself to be. EEG measures electronic potential differences on the scalp. On the other hand, MEG is a non-invasive technique for recording the activity of neurons in the brain, through recording of magnetic fields caused by synchronized neural currents. It has the ability to detect seizures. Because magnetic signals of the brain vary, this technique must balance two key problems: weakness of the signal and strength of the noise. The EEG is sensitive to extra-cellular volume currents, whereas the MEG primarily registers intra-cellular currents. Because electrical fields are quite dependent on the conductive properties of the tissues, and magnetic fields are significantly less distorted by tissue, the MEG has better spatial resolution. There is a great deal of evidence that EEG and MEG provide complementary data about underlying currents of ions. The complex relationship of sleep and epilepsy is well known. Sleep has been used for many years as a powerful EEG activator. Many researchers have supported the hypothesis that there is a specific activating effect of sleep deprivation on epileptic discharges. Sleep deprivation is defined as a sleepless state of longer than 24 hours. The increased use of MEG in diagnosis could improve the procedure for evaluating patients before surgery for epilepsy, by making invasive studies less necessary. Patients 18 years of age or older, with a diagnosis of epilepsy and with a documented last routine EEG (at least 2 weeks earlier) and routine EEG on the day of a baseline MEG-EEG without interictal epileptiform discharges (IEDs) may be eligible for this study. Participants will be rated according to the Epworth, Stanford, and Karolinska Sleepiness Scales, to determine their subjective sleepiness. They will be randomly assigned to stay awake all night or sleep in the hospital overnight. That is, a sleep deprivation and non-sleep deprivation synchronized MEG-EEG recording will be performed in random order. Then the sequence of sleep deprivation and non-sleep deprivation will be reversed within 14 to 21 days. During the recordings, the patient will either sit or lie with his or her head in a helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way audio communication will be maintained with the patient. Recording sessions will last 90 to 180 minutes, with the patient allowed to take breaks after at least 10 minutes in a scanner. Attempts will be made to encourage patients to stay awake and sleep for about the same amount of time during each recording, to acquire comparable amounts of sleep and awake recordings.

NCT ID: NCT00071305 Completed - Epilepsy Clinical Trials

Non-Invasive Seizure Localization in Patients With Medically Refractory Localization Related Epilepsy: Synchronized MEG-EEG Recordings

Start date: October 17, 2003
Phase: N/A
Study type: Observational

This study will evaluate the magnetoencephalography (MEG) alone and together with electroencephalography (EEG) in non-invasive presurgical evaluation. It will look at the contribution of those methods in determining the location of the epilepsy seizure, compared with doing so through an invasive method. EEG measures electronic potential differences on the scalp. On the other hand, MEG is a non-invasive technique for recording the activity of neurons in the brain, through recording of magnetic fields caused by synchronized neural currents. It has the ability to detect seizures. Because magnetic signals of the brain vary, this technique must balance two key problems: weakness of the signal and strength of the noise. The EEG is sensitive to extra-cellular volume currents, whereas the MEG primarily registers intra-cellular currents. Because electrical fields are quite dependent on the conductive properties of the tissues, and magnetic fields are significantly less distorted by tissue, the MEG has better spatial resolution. There is a great deal of evidence that EEG and MEG provide complementary data about underlying currents of ions. Patients 18 years of age or older who have epilepsy that is not relieved, and who are considered candidates for surgery and who accept epilepsy surgery, may be eligible for this study. Before they have surgery, participants will either sit or lie down, with their head in a helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way audio communication will be maintained with the patient. Acquiring data from the participant will be conducted during several sessions, each lasting from 10 to 60 minutes, not exceeding a total of 120 minutes. If the first recording is not of sufficient quality, the patient may have it repeated once or twice. Those participants who are found to have a clear seizure focus will proceed directly to surgery that is part of their treatment. Those whose seizure focus is ambiguous will proceed to invasive monitoring. Participants will be followed in the outpatient clinic at intervals of 1, 3, 6, and 12 months. They may periodically undergo reimaging as considered appropriate.

NCT ID: NCT00067210 Completed - Epilepsy Clinical Trials

Reducing Seizure Frequency Using Cooling of the Head and Neck

Start date: August 11, 2003
Phase: Phase 2
Study type: Interventional

Doctors use cooling of the brain to help stop seizures. This procedure is usually accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding the need for surgery. The purpose of this study is to assess a head-neck cooling device that the patient can wear. Researchers will determine whether the device can change the frequency of seizures in people with epilepsy. Study participants must be 21 years of age or older and must experience seizures that occur once a week on a regular basis. Participants will be asked to keep a detailed seizure diary for a 12-week period before the date of the first cooling session. For each of the four cooling sessions, participants will be admitted to the hospital overnight. They will undergo a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a temperature-sensor pill. Participants will have one 60-minute cooling session once a week for 4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm, abdomen, and leg. Participants will then be fitted with the cooling unit and the session will begin.

NCT ID: NCT00064467 Completed - Epilepsy Clinical Trials

Lethargic Depression Study

Start date: June 2003
Phase: Phase 3
Study type: Interventional

This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.

NCT ID: NCT00056576 Completed - Clinical trials for Epilepsy, Complex Partial

Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

Start date: February 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.

NCT ID: NCT00050947 Completed - Epilepsy Clinical Trials

Pediatric Epilepsy Study

Start date: July 2002
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.