MS Research Trials and Studies
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to collect pilot data on the effects of Naboso® Neuro insoles on persons with MS, who have impaired sensation of their feet, including their perceived foot awareness, stability, and fear of falling, along with their balance and mobility. The information gained from this study may be used to determine the effectiveness of the insoles on improving foot awareness, stability, balance and walking on persons with MS who have impaired foot sensation. | |
| Status | Open to enrollment | |
| Site Principal Investigator | Lindsay Neto, MPH | |
| Contact Name | Heather DelMastro, MS Study Coordinator | |
| Phone | (860) 714-3005 | |
Examine the Feasibility, Validity and Reliability of the Five Times Sit to Stand Test Via Telehealth in Persons with Multiple Sclerosis
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to determine if the Five Time Sit to Stand Test (FTSTS) can be easily, reliably, and safely used over telehealth services, as well as determine if the FTSTS test can be used to measure strength in persons with neurological conditions. This research is being done because Telehealth is becoming more common for physical therapy, and the information gained from this study will inform clinicians if the FTSTS is an easy to use, valid, and reliable outcome measure for this population for telehealth. | |
| Status | Open to enrollment | |
| Site Principal Investigator | Heather DelMastro, MS | |
| Contact Name | Heather DelMastro, MS | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Short Description: | This study aims to develop a fatigue self-management program for persons with MS that 1) includes both cognitive behavioral and energy conservation strategies and 2) is available as a mHealth application: Managing My MS My Way (M4W). In order to make this program meaningful for persons with MS living with fatigue, we will be including persons with MS as stakeholders in each step of the application development so that we can capture their thoughts on the application and its content. By doing so, we will ensure that the strategies included will be helpful for persons with MS, the layout and content of the application are user friendly, and that M4W is accessible and easy-to-use. | |
| Status | Open to enrollment | |
| Site Principal Investigator | Elizabeth Gromisch, PhD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: NCT05129293 | NCT05129293 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Short Description: |
Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial. The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments. |
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| Status | Open to enrollment | |
| Site Principal Investigator | Elizabeth Gromisch, PhD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
The plasma level of tetrahydrobiopterin (BH4) in persons with multiple sclerosis (PwMS): An explorative study to establish the plasma level of BH4 in relation to MS associated oxidative stress
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Mercy Medical Center 175 Carew Street Ste 150 Springfield, Massachusetts 01104 |
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| Short Description: | The purpose of this study is to investigate the association between tetrahydrobiopterin (BH4), a naturally available compound in the blood, with MS disease. Blood samples collected from both person's with MS and healthy controls may be used in analysis to measure the level of BH4 (naturally occurring chemical in the body) that may or may not be affected by MS. Samples will also help to define characteristics of person's with MS to make progress in advancing MS research. | |
| Status | Open to enrollment | |
| Site Principal Investigator | Zaenab Dhari, MD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: NCT03291756 | NCT03291756 | |
| Location | Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Short Description: | This registry study is looking to learn more about MS, how doctors treat MS, how well medications and other treatments work, the safety of those treatments, and how to improve the care and outcomes of persons with MS. Detailed clinical and health information will be collected and entered into the CorEvitas Registry database. | |
| Status | Open to enrollment | |
| Site Principal Investigator | Stacey Panasci, PA-C | |
| Contact Name | Carolyn St. Andre, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this research is to capture longitudinal physician-reported and clinical information, in a standardized manner, from people with multiple sclerosis over a long period of time. The project will follow along the routine clinical care of each participant, and collect information regarding their disease course from inception of the disorder through the lifespan of the individual. The database will bring together information collected in multiple registries and databases across the U.S. and Canada. | |
| Status | Open to enrollment | |
| Site Principal Investigator | Jennifer Ruiz, PT, DPT | |
| Contact Name | Carolyn St. Andre, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | Abstract routinely collected clinical data to establish a de-identified database of disease characteristics in persons with Multiple Sclerosis (pwMS). Conduct exploratory analyses to identify patient and disease characterteristics that are associated with various aspects of mobility. The results of these analyses will be used as pilot data to plan more complex prospective studies. | |
| Status | Active, but not recruiting. | |
| Site Principal Investigator | Jennifer Ruiz, PT, DPT | |
| Contact Name | Carolyn St. Andre, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT02759211 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward walking. | |
| Status | Closed to enrollment, in data analysis phase only. | |
| Site Principal Investigator | Jennifer Ruiz, PT, DPT | |
| Contact Name | Heather DelMastro, Study Coordinator | |
| Phone | (860) 714-2620 | |
A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)
| ClinicalTrials.gov Identifier: | NCT02047097 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to gain a better understanding of the benefits and risks of long-term treatment with Tecfidera in patients with multiple sclerosis and to collect information on any serious side effects that may occur in patients taking Tecfidera. | |
| Status | Closed to enrollment, in data analysis phase only. | |
| Site Principal Investigator | Renee Thompson, PA-C | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT01399957 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | Ampyra (dalfampridine) has been approved by the FDA for improving walking speed in persons with multiple sclerosis (MS). This observational study was designed to capture information on additional possible benefits person’s taking Ampyra may or may not experience. This project seeks to determine factors that will predict a response (an increase in walking speed) to dalfampridine. A second goal is to identify possible additional benefits to taking Dalfampridine. | |
| Status | Closed to enrollment, in data analysis phase only. | |
| Site Principal Investigator | Jennifer Ruiz, PT, DPT | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT02398149 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to characterize upper extremity involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability & Health (ICF) domains and constructs. One’s upper extremity (UE) function is critical to maintaining independence in daily activities and community participation. A better understanding of how the UE affected in persons with MS is needed to help provide necessary information to develop individualized treatment plans to promote maximum functional independence. Information collected in this study will be used to help prioritize the design and selection of future clinical care and rehabilitative interventions. | |
| Status | Closed to enrollment, in data analysis phase only. | |
| Site Principal Investigator | Jennifer Ruiz, PT, DPT | |
| Contact Name | Heather DelMastro, Study Coordinator | |
| Phone | (860) 714-2620 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The goal of this study is to establish normative LE isometric strength values in pwMS, which will be utilized to assess therapeutic interventions and functional deficits. There has been a push for further evaluation of optimal study designs and regimens of rehabilitation techniques to improve treatment of functional deficits. In order to make these improvements, some basic normative information is necessary for the establishment of goals, better understanding of the population, and to measure changes of functional capacity. This study will measure impairment level, which is necessary to guide future interventions on functional capacity. The information will be collected at a one-time, observational visit at the Mandell Center for Multiple Sclerosis in Hartford, CT. | |
| Status | Closed to enrollment, in data analysis phase | |
| Site Principal Investigator | Heather DelMastro and Jennifer Ruiz, PT, DPT | |
| Contact Name | Heather DelMastro, Study Coordinator | |
| Phone | (860) 714-2620 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Short Description: | The purpose of this study is to understand if certain background, disease-related, or clinical factors are associated with lower self-management skills in persons with MS. People with lower self-management skills may struggle with some of the changes caused by their MS, such as emotional effects or adjustments needed in their daily lives. Understanding the risk factors of lower self-management can help healthcare providers identify people who may need additional support or resources to successfully manage their MS. | |
| Status | Closed to Enrollment, in data analysis phase | |
| Site Principal Investigator | Elizabeth Gromisch, PhD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: NCT03963492 | NCT03963492 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | This study will compare the effectiveness of a traditional, continuous walking rehabilitation program for people with MS to the novel intervention of an intermittent or interval walking rehabilitation program. | |
| Status | Closed to Enrollment, in data analysis phase | |
| Site Principal Investigator | Jennifer Ruiz, PT, DPT | |
| Contact Name | Heather DelMastro, Study Coordinator | |
| Phone | (860) 714-2620 | |
Characterization of Perceived Health Related Quality of Life and Healthcare Resource Utilization in Persons with Multiple Sclerosis with and without Vascular Comorbidity
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Short Description: | This study is looking to describe the quality of life and healthcare use of persons with multiple sclerosis with and without a vascular condition through the use of a web-based survey. The survey can be taken by following this link: http://is.gd/MandellVascularStudy. | |
| Status | Closed to Enrollment, in data analysis phase | |
| Site Principal Investigator | Lindsay Neto, MPH | |
| Contact Name | Lindsay Neto, Study coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Saint Mary’s Hospital 56 Franklin Street Waterbury, CT 06706 |
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| Short Description: | Finding effective treatments for persons with multiple sclerosis is essential for patient care. One approach is self-management programs, which help patients become more actively involved in their care. This study is looking to explore how a self-management program for persons with multiple sclerosis, receiving care at the Mandell Center should be carried out and what topics it should cover through a series of focus groups. | |
| Status | Closed to enrollment, in data analysis phase only | |
| Site Principal Investigator | Elizabeth Gromisch, PhD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | n/a | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to identify genes that influence a person’s susceptibility to multiple sclerosis (MS). This study was designed and is run by the University of California, San Francisco. The Mandell Center is a recruitment site for this project in order to offer people in the Connecticut area the opportunity to enroll in this important endeavor. | |
| Status | Closed to Enrollment | |
| Site Principal Investigator | Mary Bailey, MD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT00835835 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | To gather pilot data on the effect of bodyweight supported treadmill-training (BWSTT) with and without the Lokomat (a robot-assisted lower extremity orthotic) on gait and balance. | |
| Status | Completed. | |
| Site Principal Investigator | Albert Lo, MD, PhD | |
| Contact Name | Jennifer Ruiz, PT, DPT, Research Manager | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT00906737 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | This study was designed to collect pilot data on the effect of task-specific focused ankle training using the Ankle-Bot device on subjects with Multiple Sclerosis (MS) who have “foot drop.” In addition the investigatores looked to compare the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving mobility of persons with MS. | |
| Status | Completed. | |
| Site Principal Investigator | Albert Lo, MD, PhD | |
| Contact Name | Jennifer Ruiz, PT, DPT, Research Manager | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT01641120 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study was to evaluate patients’ views when injecting Avonex® intramuscularly (IM). The study compared two needle sizes for intramuscular injection. This research was conducted to assess patients’ preference when injecting Avonex®.. | |
| Status | Completed. | |
| Site Principal Investigator | Peter Wade, MD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT01070836 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of the STRATIFY-2 study is to better understand whether antibodies to JCV may be used to predict if a patient is at a higher or lower risk of developing a rare brain infection known as Progressive Multifocal Leukoencephalopathy (PML). TYSABRI® is a medication that is associated with an increased risk for developing PML, and JC is a virus linked to PML. | |
| Status | Closed. | |
| Site Principal Investigator | Albert Lo, MD, PhD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
| ClinicalTrials.gov Identifier: | NCT00477113 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients with multiple sclerosis (MS) treated with TYSABRI®. | |
| Status | Closed. | |
| Site Principal Investigator | Peter B. Wade, MD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |
Long Term, Prospective, Multinational, Parallel-Cohort Study Monitoring Safety in Patients with MS Newly Started on Fingolimod Once Daily or Treated with Another Approved Disease-Modifying Therapy
| ClinicalTrials.gov Identifier: | NCT01442194 | |
| Location | Mount Sinai Rehabilitation Hospital 490 Blue Hills Ave Hartford, CT 06112 |
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| Short Description: | The purpose of this study is to evaluate the long-term safety of GILENYA and to further explore the incidence of selected safety outcomes in patients with multiple sclerosis, either newly prescribed GILENYA or receiving another approved MS medication. | |
| Status | Closed. | |
| Site Principal Investigator | Robert Krug, MD | |
| Contact Name | Lindsay Neto, Study Coordinator | |
| Phone | (860) 714-3005 | |