3 Clinical Trials for Various Conditions
Patients will be selected for cold intolerance after finger amputation or replantation. They will be given Botox or placebo dose as treatment and assessed over 3 months.
Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, and weakened function of the associated limb. Even after surgical intervention to repair the affected artery, people may still experience numbness, problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are particularly relevant in the case of forearm arterial repairs because this repair directly affects one of our most vital structures: the hand. Despite available interventions and advances in microsurgical technique, arterial repairs can still result in significant sensory and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's primary goal is to restore blood flow to the hand and prevent functional impairment. Even with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and motor function is hard to predict. Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level of the hand. In this study, we are investigating the occurrence of blood vessel occlusion in the arm after at least 6 months of surgery and the impact of this event. To assess this we will use physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess pain, sensory, and motor impairments in both the affected and unaffected hand. Functional assessments will include 2-point discrimination, grip strength, pinch strength, capillary refill and range of motion.
This study will examine whether certain procedures that do not involve the use of medications can reduce symptoms of neurocardiogenic syncope (SIN-ku-pe), or a condition involving recurrent fainting. This condition is also known as vasovagal syncope or neurally mediated hypotension. Neurocardiogenic syncope is a disorder of the autonomic nervous system, which controls automatic body functions such as blood pressure, heart rate, and sweating. That system can be affected by medications, conditions of the mind or body, and by a person's surroundings. Researchers in this study wish to learn whether hypnosis, hand exercises, education, or diary keeping can affect the autonomic nervous system and improve symptoms of neurocardiogenic syncope. Patients age 18 or older who have neurocardiogenic syncope may be eligible for this study. Those who have a medical illness making it unsafe to participate, who cannot discontinue certain medications, or who are pregnant are not eligible. Patients will undergo a medical history and physical examination, complete a questionnaire, and experience Valsalva and tilt table tests. These tests will take about 5 hours during 1 to 2 days. The Valsalva test evaluates some of the reflexes of autonomic nervous system. Patients will lie flat on a padded table and have sensors placed on the body, to measure blood pressure, breathing rate, and other functions. They will blow into a sterile tube for 12 seconds while the body's responses are measured. The procedure may need to be repeated several times. During the test, an intravenous tube, guided by a needle, will be placed in the patient's arm. The tube will be used to collect samples of blood (less than 7 tablespoons) to measure chemicals such as adrenaline. For the tilt table test, a patient will lie on a padded, motorized table and have sensors placed on the body. Velcro straps will be placed around the patient's body to help hold him/her on the table. Then the table will tilt the patient from a flat position to an upright one in about 10 seconds. The patient will stay upright for 45 minutes while symptoms are monitored, measurements are taken, and blood samples are collected through the intravenous tube. Then the table will be returned to the flat position. If the patient faints or is about to faint, or if he or she has an unsafe heart rhythm before the 45 minutes is over, the test will be stopped and the table will be returned to the flat position. Symptoms will be treated as needed. Patients who qualify for further study will then become familiar with hypnosis and be evaluated for their natural ability for experiencing it. A professionally trained doctor will guide patients into a hypnotic state, and patients will be asked to respond to various suggestions. They will be videotaped, an activity that will require a separate consent form. Following these procedures, patients will be assigned to one of the four groups in this study. Those in the hypnosis group will have weekly sessions for 6 weeks, with each session lasting about 1-1/2 hours. The education group will meet a study investigator for learning about syncope and the autonomic nervous system, with each session lasting about 1-1/2 hours once a week for 6 weeks. The hand exercise group will be taught certain hand exercises to perform, at home and as instructed, for 6 weeks. The diary group will receive instructions on keeping a diary pertaining to their condition, at home, for 6 weeks. After 6 weeks, patients will return for an evaluation to include completion of questionnaires and another tilt table test and blood collection by intravenous tube. This entire study will take about 8 weeks. There may be direct benefits from participating in this study. The experimental procedures may help patients' neurocardiogenic syncope. After completing this study, patients will be offered any or all of the experimental procedures tested in this study upon their request and at the discretion of the principal investigator. For example, a patient who is assigned to the diary group may be offered hypnosis, education, and hand exercise instruction after completion of the study.