Validation of computer-based saccade measures as a sensitive, reliable, and freely available biomarker for tracking subtle neurocognitive changes in Parkinson's disease

Date Added
March 28th, 2014
PRO Number
Pro00031260
Researcher
Travis Turner

List of Studies


Keywords
Parkinsons
Summary

We will ask 80 patients with Parkinson's disease, representing the full spectrum of motor and cognitive symptoms, to participate. Participation will include measurement of eye movements using two methods: the new computer-based saccade battery and the best available video-based eye-tracking equipment. The evaluation will be repeated about 30 days later. Data will be analyzed to determine whether the computer-based tasks are reliable and able to provide the same quality of information as the gold standard in eye-tracking. A comparison sample of 80 healthy older adults will also complete the behavioral saccade tests in order to establish normative data that will enable application in clinical settings.

Institution
MUSC
Recruitment Contact
Travis Turner
619-788-3079
turnertr@musc.edu

Intacs Inserts-Prescription Inserts for Treatment of Patients with Keratoconus (HDE)

Date Added
November 17th, 2015
PRO Number
Pro00046816
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

IntacsĀ® Corneal Implants is a FDA Humanitarian Use Device (HUD) designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Neural Determinants of Age-Related Change in Auditory-Visual Speech Processing

Date Added
September 24th, 2017
PRO Number
Pro00070971
Researcher
James Dias

List of Studies


Keywords
Aging, Brain, Central Nervous System, Ears, Healthy Volunteer Studies, Hearing, Language, Minorities, Vision/ Eye
Summary

Older adults typically have trouble identifying the speech they hear, especially in noisy environments. Fortunately, compared to younger adults, older adults are better able to compensate for difficulties identifying the speech they hear by recruiting the visual system. However, the extent to which older adults can benefit from visual input, and how this influence relates to age-related changes in brain structure and function, have not been thoroughly investigated. The general purpose of this study is to determine how age-related changes in brain structure and function affect how well people hear and see. This study seeks participants with normal hearing to mild hearing loss, who also have normal or corrected-to-normal vision.

Institution
MUSC
Recruitment Contact
James Dias
(843) 792-3921
diasj@musc.edu

Integrated Analysis of Vision Quality with Aberrometry

Date Added
March 27th, 2018
PRO Number
Pro00074857
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to identify and measure refractive errors of the eye as well as visual symptoms after cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Integrated Analysis of Toric Intra-Ocular Lens Rotation with Ray-Tracing Aberrometry

Date Added
March 4th, 2019
PRO Number
Pro00081873
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this project is to identify the postoperative alignment of toric intraocular lenses (IOLs) in patients who have undergone cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

A Phase 3/4, Prospective, Randomized, Active Treatment Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Date Added
September 28th, 2021
PRO Number
Pro00114633
Researcher
Marion Wilson

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to test the safety of an investigational drug product, IBI-10090 (DEXYCU), in children to treat eye inflammation (redness) caused by cataract surgery. DEXYCU was approved by the FDA in February 2018 for use in adults, however; has not yet been approved for use in children. The active ingredient in DEXYCU is dexamethasone. Instead of being an eye drop containing dexamethasone, DEXYCU remains in the eye as a tiny droplet and slowly releases dexamethasone over a period of approximately two to three weeks. After that time the droplet is absorbed by the body. Subjects 0 to 3 years of age who are undergoing cataract surgery will be eligible for this study. The study starts at screening visit which is 3-29 days before surgery. Any study-related procedures will be performed only after obtaining informed consent. Child will be in the study for about 90 days after signing informed consent. Enrollment in this study requires a total of 8 visits. If child is eligible he/she will be randomly assigned (like the flip of a coin) to either study group DEXYCU or control group, prednisolone acetate. Child will have study visits 1 day following cataract surgery, and then at approximately 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months after surgery. All visits are standard of care visits for all cataract surgery patients except 2 weeks and 6 weeks after surgery visits.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@muscs.edu

Syntactic Bootstrapping in Toddlers

Date Added
August 2nd, 2022
PRO Number
Pro00122285
Researcher
Sabrina Horvath

List of Studies

Keywords
Language, Pediatrics, Speech Disorders
Summary

Learning new words is challenging for all toddlers, and it may be particularly challenging for toddlers who are late talkers. In this study, we ask whether late talkers use the same cues to figure out the meanings of new words as do their typically developing peers. Toddlers ages 2.0-2.5 will watch videos of people doing new actions and hear made-up words. An eye-tracking device will capture their face and their gaze patterns, and we will use this data to determine how they are making sense of the new words they are hearing. Results will provide insights into how toddlers learn new words and whether this process relates to toddlers' current language abilities.

Institution
MUSC
Recruitment Contact
Sabrina Horvath
843-792-9363
horvaths@musc.edu

Identification of Differences in Verb Learning between Late Talkers and Typically Developing Children

Date Added
October 4th, 2022
PRO Number
Pro00123522
Researcher
Sabrina Horvath

List of Studies

Keywords
Language, Pediatrics, Speech Disorders
Summary

This study explores the best way to teach two-year-old toddlers new verbs, and whether there are differences in what is best between late talkers and typically developing children. In a series of two, one-hour visits, children will watch videos on an eye-tracker, which will capture their face and gaze patterns. This data will be analyzed to see how children are making sense of what they are hearing. In one task, we ask whether it is better for children to hear a new verb before they see the action it denotes, or whether it is better to see the new action before hearing the verb. In the second task, we consider how quickly children are able to make sense of the language they hear, and whether this has any relationship to how they learn new verbs (Task 1). Results will help shape new clinical interventions for late talkers.

Institution
MUSC
Recruitment Contact
Sabrina Horvath
843-792-9363
horvaths@musc.edu

Developing a method of reducing the strength of transcranial focused ultrasound (tFUS) to personalize treatment.

Date Added
March 5th, 2024
PRO Number
Pro00132894
Researcher
Mark George

List of Studies


Keywords
Vision/ Eye
Summary

Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. We do not yet have an easily observable way to know whether we are in the right brain location with the correct dose for that person. We wonder if we can produce a transient change in someone's visual field, called a scotoma, and whether we can use that to determine the minimum tFUS dose for that person.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843 876 5142
hollanbr@musc.edu

MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)

Date Added
April 23rd, 2024
PRO Number
Pro00136151
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is for those with Transthyretin (TTR) Amyloidosis with Cardiomyopathy or ATTR-CM. ATTR-CM is a condition where the heart muscle does not pump your blood through your body as it should because of build up of abnormal protein between the muscle fibers in your heart. The specific protein is called transthyretin amyloid (TTR). The study involves an investigational drug called NTLA-2001. Investigational means it is not approved for commercial sale or use by the Food and Drug Administration. This study is a randomized study meaning participants will be assigned by chance to receive NTLA-2001 or placebo. A placebo looks like the investigational drug but contains no active ingredient. In this study, two out of three participants are assigned to receive NTLA-2001 and one out of three will receive placebo. NTLA-2001 or placebo are given by intravenous (IV) infusion meaning in your vein.

NTLA-2001 consists of a gene editing system which can "knockout" the TTR gene and permanently change the DNA (deoxyribonucleic acid, which contains information that determines parts in traits such as eye color or height, that are passed on from parent to child) so the gene stops making the TTR protein.

This study will last at least 18 months and include up to 17 visits. Study related procedures include physical exams, blood work including genetic testing, eye exam, hall walk test, electrocardiograms (ECGs), echocardiogram (echo) and vitamin A supplement. Study risks include infusion related risks like headache, fever, chills, or increased liver enzymes. Other study related risks include genetic risks, loss of confidentiality and unknown risks.

Institution
MUSC
Recruitment Contact
Virginia Theodorof
843-876-9078
theodoro@musc.edu



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