Title: Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury
Principal Investigator: unknown
Funder/Sponsor: University of Rochester
Timeline: June 2010 – June 2012
Location: New York
Description: Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.
Contact: kanakadurga R Poduri, MD 585-275-3274 KR_Poduri@urmc.rochester.edu
Title: The Effect of Nitric Oxide on Pulmonary Resistances and Blood Pressure in Persons with Tetraplegia
Principal Investigator: Miroslav Radulovic
Funder/Sponsor: Department of Veterans Affairs
Timeline: Dec 06-ongoing
Location: New York
Description: The primary purpose of this study is to determine the levels of exhaled NO (FeNO) in individuals with chronic cervical spinal cord injury (SCI), and to compare them with those obtained in age and sex matched able-bodied individuals and subjects with stable mild to moderate asthma. If the FeNO levels are high and comparable to those found in asthmatic subjects, this will imply the role of chronic inflammation in reduced baseline airway caliber and non-specific airway hyper-responsiveness (AHR) exhibited by individuals with chronic cervical SCI. If the FeNO levels are comparable with those found in able-bodied controls, this will support our previous statement that unopposed cholinergic innervation is responsible for low baseline airway caliber and AHR in individuals with chronic tetraplegia. Further scientific conclusions about NO and its role in control of airway tone, pulmonary resistances and blood pressure will be drawn upon intravenous and inhaled administration of L-NAME. This compound has been shown promising results for the treatment and prevention of orthostatic hypotension in individuals with tetraplegia. Knowing its effects on airways and potential of easier mode of delivery (inhalation vs. intravenous) is of utmost importance.
Contact: Michael F LaFountaine, EdD 718-584-9000 ext 3121 Michael.lafountaine@va.gov
Title: Intranasal Administration of Neostigmine and Glycopyrrolate for Bowel Evacuation
Principal Investigator: Mark A. Korsten
Funder/Sponsor: Department of Veterans Affairs
Timeline: Feb 07-Feb 11
Location: New York
Description: DWE (difficulty with evacuation) is a common and an important quality of life issue after spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the results are often suboptimal in terms of complications such as incontinence and impaction. Bowel care regimens after spinal cord injury have not changed in any significant fashion in many years. The usual strategies for attaining bowel evacuation involve dietary manipulation (e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories). Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also require extensive nursing care. Finally, incomplete evacuation could contribute to fecal incontinence that has significant morbidity in these patients. In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote bowel evacuation in the SCI population. In an effort to provide a more realistic administration of this procedure, we propose to test the intranasal spray injection of neostigmine and glycopyrrolate for safety and efficacy.
Contact: Robert E Williams 718-584-9000 ext 3126 robert.williams206485@va.gov
Title: Pilot Study: The Role of Migration Inhibitory Factor (MIF) in Spinal Cord Injury
Principal Investigator: Ona Bloom
Funder/Sponsor: North Shore Long Island Jewish Health System
Timeline: May 2009 – December 2010
Location: New York
Description: The purpose of this study is to evaluate substances that may be present in the blood after a spinal cord injury (SCI). Specifically, the study will evaluate the presence and levels of a protein, macrophage migration inhibitory factor (MIF), in the blood of patients who have had a SCI. Blood samples from patients who have had a SCI and healthy individuals will be studied to measure MIF levels. MIF is released by cells and has a specific effect on the way cells behave, communicate and work together. In several other medical conditions, MIF is known to increase inflammation in the body. By comparing blood samples from spinal cord injury patients and normal healthy individuals, the investigators will try to find out if MIF levels are increased in people with SCI. Investigators will also use these samples to see if the biological activities of MIF can be reduced in a test tube by adding other substances to the blood samples. It is hoped that this study of MIF will help improve the treatment of SCI in the future.
Contact: Gulru Sharifova 516-562-1012 gsharifo@nshs.edu
Julie Martusciello 516-562-1012 jmartusc@nshs.edu
Title: Efficacy and Safety of Bowel Preparations for Colonoscopy in SCI
Principal Investigator: Mark A. Korsten
Funder/Sponsor: Department of Veterans Affairs
Timeline: Mar 09-May 12
Location: New York
Description: Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may also be unreliable if bowel evacuation is unsatisfactory for complete large bowel visualization. Poor colonoscopic visualization is a major concern in persons with SCI because they have long-standing difficulty with evacuation (DWE) and might not respond in a predictable or satisfactory manner to the conventional bowel preparations used for colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon cancer mortality may not be realized. In the absence of effective regimens for bowel preparation in persons with SCI, we suspect that the documented benefits of screening colonoscopy in the able-bodied may not generalize to persons with SCI. Regardless, these observations support the need for improved bowel preparation approaches in persons with SCI. One such approach might involve the adjunctive administration of prokinetic drugs to standard practices. A prokinetic agent that might be beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied neostigmine extensively in persons with SCI and have shown that, when given in combination with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for bowel evacuation.
Contact: Robert E Williams 718-584-9000 ext 3126 robert.williams206485@va.gov
Racine R Emmons 718-584-9000 ext 5246 racine.emmons@va.gov
Title: Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
Principal Investigator: Ann M. Spungen
Funder/Sponsor: Department of Veterans Affairs
Timeline: Oct 06-Oct 12
Location: New York
Description: Individuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson’s disease, and multiple sclerosis often lose their ability to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may also affect many systems and organs in the body. The investigators are interested in obtaining a wide variety of data in order to obtain a better understanding of changes that occur as a result of receiving Lokomat therapy. The investigators will be studying body composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week clinical therapy program.
Contact: Pierre K Asselin 718-584-9000 ext 3124 Pierre.Asselin@va.gov
Title: Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis
Principal Investigator: William Bauman
Funder/Sponsor: Department of Veterans Affairs
Timeline: April 03- Sept 10
Location: New York
Description: Insulin-like growth factor I (IGF-I) is used as a measure of the body’s ability to produce growth hormone. Growth hormone is important for muscle tissue as well as many other tissues in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I levels. IGF-I levels will be determined before and after treatment with baclofen. In this study, the investigators will determine the minimum dose of baclofen at which improvements in GH and IGF-1 levels occur.
Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury
Principal Investigator: Greg Schilero
Funder/Sponsor: Department of Veterans Affairs
Timeline: Apr 07-Dec 11
Location: New York
Description: The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.
Contact: Michael F LaFountaine, EdD 718-584-9000 ext 3121 Michael.lafountaine@va.gov
Title: The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons with Spinal Cord Injury
Principal Investigator: William Bauman
Funder/Sponsor: Department of Veterans Affairs
Timeline: February 2010 – October 2013
Location: New York
Description: Although conventional risk factors for coronary heart disease (CHD) have been identified and routinely used to determine risk for CHD in the general population, a systematic approach to determine population-specific risk for CHD has not been performed prospectively in those with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD are high serum concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family history of premature CHD. Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. Studies have shown that a strong association exists between coronary calcification and coronary heart disease. The purpose of this study is to compare the CAC scores in persons with SCI with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (CAD) and to determine the relationship between CAC scores and conventional and emerging risk factors for CAD.
Title: A Dose Response Trial Using 5 and 10 mg. of Midodrine Hydrochloride to Treat Orthostatic Hypotension in Persons with SCI
Principal Investigator: Jill Wecht
Funder/Sponsor: Department of Veterans Affairs
Timeline: Jan 07- Mar 11
Location: New York
Description: Following SCI, individuals often experience the inability to adjust to postural changes due to disruption of central command of the baroreceptor reflex and reduction in efferent sympathetic neural pathways; consequently, orthostatic hypotension (OH) and symptoms of cerebral hypo-perfusion may ensue. OH is a well-documented phenomenon, which is characterized by a fall in systolic blood pressure of >20 mmHg or diastolic BP of > 10 mmHg within 3 minutes of assumption of an upright posture. As a consequence of OH, many individuals experience symptoms of cerebral hypo-perfusion which include lightheadedness, dizziness, blurry vision, fatigue, nausea, ringing in the ears, cognitive impairment and heart palpitations. Although several investigators have reported increased prevalence of OH during the acute phase of spinal cord injury (SCI), individuals with chronic injury also experience significant falls in blood pressure with seated upright postures. This investigation will examine the effects of an alpha-agonist, midodrine hydrochloride, during head-up tilt on systemic blood pressure, cerebral blood flow and cerebral oxygenation compared to placebo administration in persons with chronic SCI who demonstrate significant orthostatic hypotension during a 24-hour observation study. This is the first study to determine the dose response and efficacy of midodrine to improve orthostatic blood pressure and cerebral blood flow and oxygenation in the SCI population.
Title: Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons with Subacute SCI
Principal Investigator: William Bauman
Funder/Sponsor: Department of Veterans Affairs
Timeline: June09-June 12
Location: New York
Description: The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury. One of the major complications in persons with spinal cord injury (SCI) is marked bone loss because it greatly predisposes to skeletal fractures, even after minimal trauma. The use of low magnitude mechanical stimulation has been shown to be both safe and effective in improving bone mass and strength in animal studies. This modality has also been shown a beneficial effect in children with disability and in postmenopausal women. The investigators are interested in obtaining data to determine the possible benefits that mechanical intervention with vibratory stimulation may have on bone in individuals with subacute SCI (e.g., >1 month after injury but <1 year). Changes in bone density and mass of the leg and arm will be determined by dual energy X-ray absorptiometry (DXA); bone architecture of the distal leg and distal arm will be determined by peripheral quantitative computed tomography; circulating metabolic markers of bone will also be performed.
Contact: Pierre K Asselin 718-584-9000 ext 3124 Pierre.Asselin@va.gov
Chris Cirnigliaro, MS 973-731-3900 ext 2755 ccirnig@yahoo.com
Title: Vitamin D and Calcium Replacement/Supplementation in Subjects with Chronic Spinal Cord Injury
Principal Investigator: William Bauman
Funder/Sponsor: Department of Veterans Affairs
Timeline: Jan 08-Jan 13
Location: New York
Description: Vitamin D aids in the body’s ability to absorb calcium, it is a vital component in bone formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and may depress serum calcium levels. The following is a list of common causes of vitamin D deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight, individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver damage, and renal failure. Many of these factors can be found in individuals with spinal cord injury. SCI results in disuse bone loss after acute injury, which continues with duration of injury. The goal of this study is to determine the effects of vitamin D and calcium supplements on calcium metabolism and vitamin D deficiency in individuals undergoing functional electrical stimulation (FES) stand retraining (SRT).
Title: Safety and Efficacy of L-NAME and Midodrine to Increase MAP in Persons with Tetraplegia
Principal Investigator: Jill Wecht
Funder/Sponsor: Department of Veterans Affairs
Timeline: May10- Mar 12
Location: New York
Description: After a spinal cord injury the brain is no longer completely in control of the body below the level of injury. This affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We are going to study blood pressure while the person is seated in a wheelchair before and after we give the subject medications which should increase blood pressure in a laboratory setting and over the course of a normal day in persons with spinal cord injury.
Contact: Dwindally Rosado Rivera, EdD 718-584-9000 ext 3128 dwindally.rosadorivera@va.gov
Title: Systemic Hemodynamics and Cerebral Blood Flow in Persons with Tetraplegia
Principal Investigator: Jill Wecht
Funder/Sponsor: Department of Veterans Affairs
Timeline: Oct 05-May 11
Location: New York
Description: The purpose of this study is to determine how blood pressure and blood flow are controlled during head-up tilt in a semi-upright position. In this investigation we are studying blood pressure and blood flow to the brain, with and without a medication which lowers blood pressure (Vasotec). We will determine how persons with a spinal cord injury are able to maintain blood flow to the brain (not get dizzy) as they assume a more upright position and their blood pressure decreases.
Title: Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain after Spinal Cord Injury
Principal Investigator: Thomas Bryce
Funder/Sponsor: Mount Sinai School of Medicine
Timeline: July 07-Ongoing
Location: New York
Description: We would like to learn if a medicine called “modified-release morphine sulfate” (Avinza) helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time. “Modified-release” means that the medicine in the capsules is slowly released to the body, instead of being released all at once. Avinza is approved by the Food and Drug Administration for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related pain.
Contact: Anousheh Behnegar, MD 212-659-9379 Anousheh.Behnegar@mountsinai.org
Jeanne M zanca, PhD MPT 212-659-9349 Jeanne.Zanca@mountsinai.org
Title: Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons with Spinal Cord Injury
Principal Investigator: William Bauman
Funder/Sponsor: Department of Veterans Affairs
Timeline: Jun08-Jun 11
Location: New York
Description: Iron overload is a life-threatening condition that can lead to liver disease, cardiac disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated free radicals. Both conditions of high and low iron stores may present with common signs and symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin, serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin. The investigators are proposing a study to determine the effect of concurrent AA and iron supplementation on iron status of individuals with SCI. The investigators goal is to identify abnormal status that may be attributed to simultaneous supplementation of iron and AA to develop future supplementation protocols in this population for optimal iron status.
Title: White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord – Pilot Study
Principal Investigator: Henning U Voss
Funder/Sponsor: Weill Medical College of Cornell University
Timeline: November 2005-ongoing
Location: New York
Description: White matter fiber tracking may provide a novel tool to assess the integrity of injured motor tracts in the cervical spine. It provides information about fiber directions which is not given by conventional MRI. White matter fiber tracking in the brain is used at several institutions, including our own medical college, for presurgical planning of tumor excision. We believe that the technical and clinical experience gained for the brain can be applied to fiber tracking in the cervical spine as well.