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Information on Clinical Trials at the Mayo Clinic

Citicoline Brain Injury Treatment (COBRIT) trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury. Citicoline (also known as CDP-Choline) is a naturally occurring endogenous compound. Citicoline may have neuroprotective effects and may potentiate neuro-recovery which has led to the evaluation of it as treatment for both stroke and TBI in animal models and in human clinical trials.

Mayo Clinic researchers are looking at a new procedure that involves surgically placing a Responsive Neurostimulator (RNS) in the brain that may be able to suppress seizures in patients with epilepsy

Patients with epilepsy undergoing deep brain stimulation (DBS) have electroencephalograms (EEGs) recorded before and during their stimulation treatment. Subsequently we will be using computer-assisted analysis of the digitally-recorded EEG signals to assess the effects of DBS on the brain-wave frequency content and any abnormal seizure-like patterns that may be present.

Study to determine if a therapy regiment of the medication Hemin can improve symptoms in diabetic patients with gastroparesis (slow gastric emptying). We want to test the effects of this new medication on the rate at which food empties from your stomach and on your symptoms

Study being conducted to learn about the effects (both good and bad) of a brain stimulating device known as the External Responsive Neurostimulating System. This is an investigational device that was designed to detect seizure activity and give an electrical stimulation to the brain to try to stop it

Completed study on Motilin, a peptide, whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore provide a potential approach to the treatment of a range of clinical conditions where delayed gastric emptying may contribute to symptoms, such as enteral feeding ntolerance (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and functional dyspepsia. This study is the First Time In Human study for the motilin receptor agonist, GSK962040.

The Medical Product Safety Network (MedSun) improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety. This website also provides public access to de-identified reports 2 sent into the MedSun program, in addition to important safety information to MedSun participants and to the national clinical community about reported problems.

Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)

As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to severe CP in the children at 2 years. The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development.

European study to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is especially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying.

Abstract - CONTEXT: Chorioamnionitis has been implicated in the pathogenesis of cerebral palsy, but most studies have not reported a significant association. Cystic periventricular leukomalacia (cPVL) is believed to be a precursor of cerebral palsy in preterm infants. OBJECTIVES of the study is to determine whether chorioamnionitis is associated with cerebral palsy or cPVL and to examine factors that may explain differences in study results.

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease. Our study will investigate how adjusting the amount of oxygen given to sick preterm newborns will affect the ability to maintain a safe oxygen level in their blood

Completed study comparing the blood drug levels of two prescribed medications, Immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Completed study examined tongue strength and endurance, how the tongue applies pressure during swallowing, and how the chin muscles react during swallowing in healthy volunteers and in patients with dysphagia (difficulty swallowing). The information from this study may be helpful in developing better treatments for people with swallowing problems

Theta-burst transcranial magnetic stimulation (TBS) is a type of repetitive transcranial magnetic stimulation (rTMS) method that reduces the excitability of a small region of brain for less than one hour. Since dystonia and spasticity may be associated with increased excitability of motor cortex, we expect that by reducing the excitability of motor cortex with TBS we will temporarily improve these symptoms and hopefully open avenues in the future for the use of TBS as a new, non-invasive therapeutic intervention to aid in physical therapy and symptom amelioration of dystonia and spasticity.

Study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies found changes in brain function in patients with the disorder that may play a role in its development.

FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite and stimulate the nerves that supply paralyzed muscles. This research will look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function

Agency for Healthcare Research and Quality (AHRQ) Study Shows Using Bar-Code Technology with eMAR Reduces Medication Administration and Transcription Errors. Press Release, May 5, 2010. Agency for Healthcare Research and Quality, Rockville, MD.