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Clinical Trials (Currently Recruiting - Volunteers Needed)If you are 18 years or older and interested in enrolling in a clinical trial, please contact the research coordinator listed for that particular clinical trial. Assistive Technology Establishing acceptable support surface interface pressure thresholds (Stephen Sprigle, PhD, GIT/Chris Maurer, Shepherd Center) [318] This is a research study about pressure ulcers (bedsores or decubitus ulcers). The purpose of the study is to measure pressure on the skin that may lead to a pressure ulcer. This study includes four tests involving measuring the pressures on the body as the subject sits in a wheelchair and lies in bed. Measurements will be made every week. Interface pressure measurements will require the most time of any test and require between 40 minutes and 1-½ hours per week. These measurements might be split into two separate test sessions of 20-45 minutes each. If required, a weekly blood test will be taken. None of these test sessions will affect or reduce the care that participants currently receive. The study will end when the subject is discharged from Shepherd Center. Contact: Chris Maurer at 404-367-1333. Multiple Sclerosis A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). Protocol 109MS301 (Ben Thrower, MD) [428] To participate in this study, you must be between the ages of 18-55, have relapsing, remitting MS, and have had one documented relapse within past year. Participants must be able to walk independently and not to have taken interferon beta medications or glateramer acetate (Copaxone) within the past 3 months. This study is not for persons diagnosed with progressive MS. Study related examinations and procedures are provided at no cost to qualifying participants. Contact: Alison Akard at 404-350-3099. A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis (SPMS). Protocol MBP8298-SP-03. (Ben Thrower, MD) [422] To participate in this study, you must be between the ages of 18-65, have secondary progressive MS, and have had documented disease progression of 2 yrs. Participants must be able to walk independently or with an assistive walking device. This study is not for persons diagnosed with relapsing remitting MS or primary progressive MS. Participants must not have been treated with Tysabri within the last two years. Contact: Carlyn Kappy at 404-367-1375. A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a (Avonex) and Glatiramer Acetate (Copaxone) to Either Agent Alone in Patients with Relapsing Remitting Multiple Sclerosis (CombiRx – Phase III) (NIH & NINDS) (Ben Thrower, MD) [325] To participate in this study, you must be between the ages of 18-60, have relapsing remitting MS, and have had 2 relapses within the past 3 yrs. Participants must be able to walk independently. This study is not for persons who have had prior use of interferon beta and glateramer acetate and/or have had a relapse within the past 30 days. Contact: Nell "Winnie" Klein at 404-367-1305. A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood Samples for Research Into the Causes of Multiple Sclerosis and Selected Demyelinating Diseases (ACP-001) (Ben Thrower, MD) [378] The purpose of this genetic registry is to establish a collection of blood samples and associated data from all MS patients and their related and unrelated family members. The samples and data will be made available to research scientists who are involved in the stuffy of Multiples Sclerosis (MS), Transverse Myelitis (TM), Acute Disseminated Encephalomyelitis (ADEM), and/or Neuromyelitis Opica (NMO), and in particular, studies involved in determining the causes of these syndromes/diseases. Contact: Elizabeth Iski at 404-350-3116. Implantable Systems Performance Registry (ISPR). Protocol NSP0010-10000 (Donald Peck Leslie, MD [346] This is an ongoing registry project with continuous enrollment and is open to Shepherd Center inpatients and outpatients. Participants must have received intrathecal baclofen pumps within the last 3 yrs. The purpose of this registry is to monitor the use and performance of Medtronic products and to better understand patient needs. Medtronic will use the information from this registry to improve its products or develop possible new products and therapies. The research involved includes data collection only and this data should be available from the participant’s medical record. Contact: Rachel Betzler at 404-367-1269.
Spinal Cord Injury An Open-label, Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects with Neurogenic Bladder following Spinal Cord Injury. Protocol TNG-CL004 (Bruce Green, MD) [417] To participate in this study, you must be 18 or older, have a history of SCI at least 12 months, and need for bladder augmentation. This study is not for females planning a pregnancy in the next 5 yrs. Participants must not have a history of recurrent bladder stones within 6 months. Contact: Amy Clavijo at 404-350-3073.
A Four Week, Prospective, Randomized, Double Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV650 in Patients with Spasticity Due to Spinal Cord Injury. Protocol AV650-014 (David Apple, MD) [425] To participate in this study, you must be between the ages of 18-70, have incomplete chronic SCI with spasticity. Participants must be willing and able to withdraw from other antispastic/muscle relaxant drugs for at least one week before randomization. This study is not for persons who have clinically significant disease processes. Contact: Michelle Nemeth at 404-350-7688. A Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects with Spasticity Due to Spinal Cord Injury. Protocol XP-B-065 (David Apple, MD) [435] To participate in this study, you must be between 18-60, have spasticity due to traumatic SCI at levels C5-T12, and able to travel to Shepherd for weekly visits for 11 weeks. This study is not for persons who have wounds of grade 3 or 4. Participants must not have clinically significant medical and/or cognitive issues. Contact: Michelle Nemeth at 404-350-7688. Stability of Vocational Interests Two Years after Spinal Cord Injury: Relationship with Employment, Participation, and Subjective Well-Being (NIDRR; James Krause, Ph.D.; Lesley Hudson, MA) [297] The primary objectives of this study are to identify how much interests change in the first two years after SCI onset, factors related to change, and the extent to which interest type and interest change are associated with employment, participation and subjective well-being. By helping rehabilitation professionals to better understand the relationships of both interest type and interest stability with employment, participation and well-being, this study will lay a foundation for intervention strategies that will maximize opportunities for participation and help people with SCI to lead fulfilling and rewarding lives. Contact: Patti Duncan at 404-350-7591. Development & testing of a handheld device for detection of erythema & bruising (Stephen Sprigle, PhD, GIT/CATEA; Kim Davis, PT, Shepherd Center) [331] The project has two related objectives. First, the project will develop non-invasive methods for the early diagnosis of pressure ulcers in patients who are at risk for developing pressure ulcers. Second, the project will develop a non-invasive method for detecting and determining the age and extent of bruises in populations at risk for physical abuse. This protocol will use multi-spectral imaging as a means for detecting both incipient pressure ulcers and bruises. Pressure ulcers frequently manifest themselves as a reddening of the effected skin. Bruising results from trauma which damages the micro-vasculature and allows blood and other fluids to seep into the tissue. Both of these skin discolorations can be easily missed in people with deeply pigmented skin. The methods developed for detection must work universally, without regard for skin color. The project aims to develop a simple, low cost, hand-held device for healthcare practitioners who currently rely on visual indicators to detect bruising or pressure ulcers. The device will assist in determining whether a bruise or pressure ulcer exists, and the age and extent of damage, without addressing the cause of the damage. This phase of the project will use multi-spectral imaging to examine all types of skin discolorations, including pressure ulcers, bruising, scars, birthmarks and hyper- and hypo-skin pigmentation. Contact: Kim Davis at 404-352-2020. Pilot Study of Effectiveness of an Upper Extremity Computer-controlled Exoskeleton Device for Retraining Movement in Individuals with Tetraplegia (Deborah Backus, PhD, PT, Stephen Sprigle, PhD, PT, David Apple, MD, Shepherd Center) [359] Contact: Debbie Backus at 404-350-7599. Pilot Study of Effectiveness of the AMES Device for Retraining Wrist and Hand Movement in Individuals with Tetraplegia (Deborah Backus, PhD, PT, Paul Cordo, PhD, David Apple, MD, Shepherd Center) [360] Paul Cordo has developed an innovative device to build new connections in the brain after neurological injury in order to facilitate functional connections and plasticity. His AMES device, couples assisted movement and enhanced sensation to treat people with arm movement deficits due to neurological deficits, such as stroke. The novelty of this approach is that it utilizes what is known regarding the benefits of repeated movement for motor learning, and combines this with the hypothesis that coincident sensory and motor demands may induce functional plasticity after nervous system injury. This device has shown promise for treating arm dysfunction due to the hemiplegia caused by stroke. This approach has not been studied in people with movement dysfunction due to SCI. The AMES device may provide an additional way for people with tetraplegia due to a SCI to retrain movement and coordination, and to regain strength in their arms. Five people with tetraplegia who have been injured longer than one year, will be enrolled in this study. Participants must be between the ages of 18 and 59, and must commit to attending training sessions 3 times per week for 12 weeks. Each session will begin with an evaluation, followed by 30 minutes of treatment based on this evaluation. Motions that will be evaluated and treated include wrist flexion and extension, and when finger movements are available, combinations of finger and wrist flexion or wrist and finger extension. While the subject assists the movement of the AMES device, the vibrators activate from the opposite muscles (e.g., when the wrist flexors are contracting for wrist flexion, the wrist extensor will be vibrated). At the end of the study, each person will be reevaluated in terms of his or her strength, coordination, function and quality of life. It is hypothesized that these individuals will experience improvements in all aspects of their arm function after use of the AMES device. Contact: Debbie Backus at 404-350-7599. Implantable Systems Performance Registry (ISPR). Protocol NSP0010-10000 (Donald Peck Leslie, MD [346] This is an ongoing registry project with continuous enrollment and is open to Shepherd Center inpatients and outpatients. Participants must have received intrathecal baclofen pumps within the last 3 yrs. The purpose of this registry is to monitor the use and performance of Medtronic products and to better understand patient needs. Medtronic will use the information from this registry to improve its products or develop possible new products and therapies. The research involved includes data collection only and this data should be available from the participant’s medical record. Contact: Rachel Betzler at 404-367-1269. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Repeat Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity in SCI patients. Protocol 191622-515-00 (Jenelle Foote, MD) [389] To participate in this study, you must be between the ages of 18-80, have urinary incontinence as a result of neurogenic detrusor overactivity for at least 3 months. Participant’s spinal cord injury must be T1 or below. This study is not for persons with a history of unexplained blood in the urine or a history of interstitial cystitis. Contact: Amy Clavijo at 404-350-3073. Brain Injury A Randomized Double-Blinded, Placebo-Controlled, Multi-Arm, Multi-Stage Study of Methylphenidate and Bromocriptine to Improve Attention in Participants with Traumatic Brain Injury Receiving Acute Rehabilitation. (Darryl Kaelin, MD; Ron Seel, PhD) [346] To participate in this study, you must be between 14-59, have a traumatic brain injury and be admitted to and estimated to remain in acute rehabilitation for at least 14 days. Must speak English as primary language. This study is not for persons who have been already diagnosed with Attention deficit disorder. Participants must not have a history of previous brain injury, brain tumor or stoke. Contact: Amy Clavijo at 404 350-3073. Note: This clinical trial is open to Shepherd Center inpatients. Implantable Systems Performance Registry (ISPR). Protocol NSP0010-10000 (Donald Peck Leslie, MD [346] This is an ongoing registry project with continuous enrollment and is open to Shepherd Center inpatients and outpatients. Participants must have received intrathecal baclofen pumps within the last 3 yrs. The purpose of this registry is to monitor the use and performance of Medtronic products and to better understand patient needs. Medtronic will use the information from this registry to improve its products or develop possible new products and therapies. The research involved includes data collection only and this data should be available from the participant’s medical record. Contact: Rachel Betzler at 404-367-1269. |
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