Validation of computer-based saccade and pupillary light reflex measures as biomarkers for progressive supranuclear palsy Save

Date Added
July 18th, 2017
PRO Number
Pro00065862
Researcher
Marian Dale
Keywords
Aging, Brain, Movement Disorders, Nervous System, Parkinsons, Rare Diseases, Vision/ Eye
Summary

This study examines eye movements and the pupil's response to light in progressive supranuclear palsy (PSP), comparing to Parkinson's disease and control subjects without neurological disease. Computerized measures of eye movements and pupil changes will be used. Subjects will also receive an eye exam to rule out other eye diseases. The goal of this study is to use subtle changes in eye movements and the pupil's response to light for earlier diagnosis of PSP.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older with Insomnia Disorder Save

Date Added
May 9th, 2017
PRO Number
Pro00066197
Researcher
Thomas Uhde
Keywords
Aging, Men's Health, Sleep Disorders, Women's Health
Summary

The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.

Institution
MUSC
Recruitment Contact
Allison Wilkerson
8437924636
wilkersa@musc.edu

Age effects on cochlear reflectance in adult humans Save

Date Added
February 13th, 2017
PRO Number
Pro00061210
Researcher
Sara Fultz
Keywords
Aging, Ears, Geriatrics, Healthy Volunteer Studies, Hearing, Minorities
Summary

This project, funded by the National Institutes of Health, is being conducted to learn how structures of the middle-ear and inner ear are affected by age and hearing ability, and to provide a scientific basis for diagnosis and rehabilitation of hearing loss. Volunteers who meet the eligibility requirements may enroll in this study, which will include measurements of hearing using several procedures. Participants 18 years of age and older with normal hearing or hearing loss are currently being recruited. One or two visits of 1.5 to 2 hours are required and scheduling is flexible. Compensation for time will be provided and parking validated.

Institution
MUSC
Recruitment Contact
Sara Fultz
843-792-0667
fultzs@musc.edu

TheraBracelet: The first and only wearable to instantly improve stroke hand function Save

Date Added
January 3rd, 2017
PRO Number
Pro00062471
Researcher
Na jin Seo
Keywords
Aging, Central Nervous System, Movement Disorders, Muscle, Nerve, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. Yet, there is no assistive device to help hand function at home, every day, during activities of daily living. This study addresses this gap by providing an innovative technology. The ?TheraBracelet? is a wristband applying imperceptible white-noise vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors? touch sensation and hand dexterity in preliminary studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. This study is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity, and to determine if TheraBracelet?s instant effects are sustained during prolonged use. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety will be assessed for the treatment condition compared to the control condition (wearing the device without vibration) through weekly evaluations. In addition, TheraBracelet?s instant benefits in improving hand function will be assessed weekly. Persistence of TheraBracelet?s instant benefits across all weekly evaluations will support durability (i.e. desensitization to vibration does not occur during extended daily use over a one-month period). This project is expected to lead to an assistive wristband that increases hand function during activities of daily living, thus increasing independence and quality of life and reducing caregiver burden for a large number of stroke survivors with hand impairment.

Institution
MUSC
Recruitment Contact
Andrew Fortune
843-792-8970
fortunea@musc.edu

Looseners versus Tighteners: Histopathology Analysis of Arthrofibrosis in Total Knee Replacement (TKA) Save

Date Added
November 3rd, 2016
PRO Number
Pro00052283
Researcher
Jacob Drew
Keywords
Aging, Arthritis, Bone, Joint, Pain, Physical Therapy
Summary

All primary total knee replacement patients will undergo the surgical procedure per the surgeon's standard technique. Samples of tissue that is ordinarily removed and discarded as a part of the procedure will be sent to the pathology lab, where the pathologist will prepare and stain the tissue sample to assess for levels of a specific protein thought to be a marker for the likelihood of the soft tissues to form dense versus loose scar tissue. We will then follow each patient's postoperative course to determine if levels of the protein in question, alpha smooth muscle actin (ASMA) correlate with outcomes. Outcomes will include postoperative pain, range of motion, as well as patient-reported satisfaction and function scores.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

Low vitamin D levels and outcomes after total knee and hip arthroplasty Save

Date Added
September 15th, 2016
PRO Number
Pro00053191
Researcher
Jacob Drew
Keywords
Aging, Arthritis, Bone, Joint, Nutrition, Surgery, Vitamin D
Summary

Low vitamin d levels are common among patients undergoing orthopedic surgery. However, very little is known about how vitamin d affects outcomes in patients undergoing total joint replacement surgery. Our study will look at how common low vitamin d status is among patients undergoing total hip and total knee replacement surgery. We will also look at how vitamin d levels affect complication rates and hospital readmission rates.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

A randomized, double-blind, placebo-controlled trial of urate-elevating inosine treatment to slow clinical decline in early Parkinson?s disease Save

Date Added
February 16th, 2016
PRO Number
Pro00051416
Researcher
Vanessa Hinson
Keywords
Aging, Brain, Drug Studies, Geriatrics, Movement Disorders, Parkinsons
Summary

The purpose of this study is to find out whether a treatment that raises urate (also known as uric acid) levels can slow the rate of worsening in Parkinson?s disease (PD). There is evidence that increased urate levels can predict both a lower risk of developing PD and a slower rate of its worsening over time. In this study, we will elevate blood urate levels with a supplement called Inosine. This research study will compare Inosine to a placebo. During this study you may get a placebo or Inosine. Study participation will consist of screening visits which include physical exam, lab work, questionnaires, and an additional scan. If you are eligible for the study, you will participate in approximately 10 study visits over approximately 2 years.

Institution
MUSC
Recruitment Contact
Nancy Feracco
843-792-7859
feracco@musc.edu

Immune response to pneumococcal vaccination in aging HIV positive adults Save

Date Added
November 17th, 2015
PRO Number
Pro00046749
Researcher
Maria anna Westerink
Keywords
Aging, Blood Disorders, Healthy Volunteer Studies, HIV / AIDS, Infectious Diseases, Vaccine
Summary

We are doing this study to find out what practice, one dose PPV23 or one dose PCV13 followed by one dose PPV23, protects better against pneumonia in older HIV-positive.

Institution
MUSC
Recruitment Contact
Myroslawa Soloshchenko
8437922218
soloshch@musc.edu

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) Save

Date Added
September 23rd, 2015
PRO Number
Pro00043151
Researcher
Jacobo Mintzer
Keywords
Aging, Alzheimers, Brain
Summary

With this research study, we want to learn if methylphenidate (Ritalin® and others) helps people with Alzheimer?s disease and apathy (lack of interest or concern for things that others find moving or exciting).

Institution
MUSC
Recruitment Contact
Catherine Danner
843-724-2302
catherine.danner@rsfh.com

Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence Save

Date Added
June 2nd, 2015
PRO Number
Pro00043450
Researcher
Teresa Kelechi
Keywords
Aging, Circulation, Diabetes, Inflammation, Skin, Vascular
Summary

Individuals with venous leg and diabetic foot ulcers often find these ulcers take a long time to heal and when they do, sometimes they come back. These ulcers can be quite painful making it hard to work, sleep and go about one's day to day activities. You will be asked to do a self-care routine of taking the temperature of the skin where the leg or foot ulcer just healed with a special thermometer and applying a small cooling gel patch over this skin. We want to know if this routine will prevent the ulcer from coming back, help you to become more active, and improve the quality of your life.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 792 4771
prenticm@musc.edu

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