9 Clinical Trials for Various Conditions
This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors.
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies.
This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 oral monotherapy in subjects with metastatic Uveal Melanoma (UM).
This study will evaluate the effect of transcranial electrical polarization (TEP), also called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck or face. When people with focal hand dystonia make small and repeated movements with their hands, there is extra activity in the part of the brain called the motor cortex. TEP is a method of brain stimulation that slows down the activity of the nerve cells in the motor cortex. This study may help researchers develop new ways to treat focal hand dystonia. People 18 years of age and older with focal hand dystonia may be eligible for this study. Participants have a neurological examination and are randomly assigned to one of two treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts of the brain used for hand movement, and the placebo group receives sham stimulation, which does not affect any area of the brain. There are three TEP/placebo sessions over a period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2 hours. For TEP, sponge electrodes are placed on the scalp and an electrical current is passed through the scalp and skull to the outer part of brain. Before and after each session, participants have a neurological examination, including an evaluation of the rate and severity of their movement problems. For this assessment, participants do a writing test while the electrical activity of their hand muscles is recorded using surface electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel are taped to the skin over the muscles being tested. Patients are followed in the clinic the day after the end of TEP treatment for evaluation of their movement abilities and the effects of therapy, such as improvement of handwriting.
This study will examine and compare brain activity in people with focal hand dystonia (FHD) and healthy volunteers to obtain further knowledge about the underlying cause of FHD. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement; FHD affects the hands and fine finger movements. During fine finger movement, the brain controls muscles in a process called surround inhibition. This process may be impaired in people with hand dystonia, leading to uncontrolled overactivity in muscles and impairing motor function. Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study. Candidates are screened with a physical and neurological examination. In a series of three experiments conducted during a single clinic visit, participants undergo transcranial magnetic stimulation (TMS) while performing a finger movement. A 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 outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, the subject is asked to contract one finger. In addition to TMS, subjects have surface electromyography. For this test, they sit in a chair with their hands placed on a pillow on their lap. The electrical activity of three muscles in the right hand is recorded by electrodes (small metal disks) taped to the skin over the muscles.
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms. Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test. All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.
This study will examine how the brain coordinates movement in patients with focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. This study will use transcranial magnetic stimulation (TMS, see below) to study how the brain plans movement. Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be eligible for this study. Healthy subjects may participate in one, two or three of the experiments described below. Patients with dystonia may participate in experiments one and three. Before each experiment, each subject is asked about his/her medical and neurologic history, complete questionnaires and will undergo a brief physical examination. Experiment 1 * Surface EMG: Small electrodes are taped to the skin over the arm to measure the electrical activity of muscles. * TMS: A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. Experiment 2 (Two visits.) * Visit 1: Magnetic resonance imaging (MRI): This test uses a magnetic field and radio waves to obtain images of body tissues and organs. The patient lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient will be asked to lie still for up to 30 minutes at a time. * Visit 2: Surface EMG and TMS Experiment 3 -Surface EMG and TMS - During the TMS, subjects are asked to respond to shapes on a computer screen by pushing a button or pressing a foot petal.
This study will examine how chemical changes in the brain produce symptoms of hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. The study will use positron emission tomography (PET) to find our which areas of the brain in patients with focal hand dystonia differ from healthy volunteers without focal hand dystonia. Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Participants undergo the following procedures: * PET scanning: The PET scanner is shaped like a doughnut. The subject lies on a bed that can slide in and out of the scanner. A custom-molded plastic mask is placed on the face and head to support the head and prevent it from moving during scanning. Two radioactive substances - five doses (one per scan) of \[15 O\] water and one dose of \[11C\] flumazil are injected into the body through a vein. The dose of injected radioactive substance is very small, and they are not harmful to the body. The \[15 O\] water doses are injected during the first hour and scans are taken every 10 minutes. The \[11C\] flumazil is injected during the second hour. The radioactive substances are detected by the PET scanner and provide information on the functioning of the brain chemistry. * MRI scanning: MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time for this study will be less than one hour. Subjects may be asked to lie still for up to 10 minutes at a time.
This study is exploring a new experimental procedure in dystonia called repetitive transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of the study is to determine whether repetitive TMS is effective as a treatment to reduce symptoms in dystonia as demonstrated by improved motor performance.