A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Date Added
January 25th, 2023
PRO Number
Pro00125181
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

The objective of this research study is to identify brain biomarkers using MRI scans that can predict an individual's response to Deep Brain Stimulation (DBS). A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSC's Clinical DBS Program. Participants will undergo two visits which include a 2.5-hour pre-DBS questionnaire and MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

BLINDED REFERENCE SET FOR MULTICANCER EARLY DETECTION BLOOD TESTS

Date Added
January 24th, 2023
PRO Number
Pro00125723
Researcher
Brian Hess

List of Studies


Keywords
Cancer
Summary

This study is for patients with cancer and is being done to see if blood samples from patients with and without certain types of cancer help researchers develop a future blood test for use in detecting cancer early.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

The efficacy of the Smart Pass filter to Reduce the Risk for inappropriate subcutaneous implantable cardioverter-defibrillator shocks from myopotential interference

Date Added
January 23rd, 2023
PRO Number
Pro00117025
Researcher
Michael Gold

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who are already implanted with a S-ICD device (Subcutaneous Implantable Cardioverter Defibrillator, which is a device designed to monitor heart rhythms and deliver a shock to the heart to stop life threatening heart rhythms), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu

POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in STANDARD RISK PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE (The ROADSTER 3 Study)

Date Added
January 12th, 2023
PRO Number
Pro00125673
Researcher
Antwana Wright

List of Studies

Keywords
Vascular
Summary

The study is to evaluate real world usage of the ENROUTE® Transcarotid Stent System when used with the ENROUTE® Transcarotid Neuroprotection System in patients with significant carotid artery disease who are at standard risk for adverse events from carotid endarterectomy (CEA). The devices used in the study are not investigational and have been approved for use by the Food and Drug Administration (FDA).

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation.

Date Added
January 10th, 2023
PRO Number
Pro00125256
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Nerve
Summary

This study's objective is to determine if electrical stimulation can safely reduced atrial fibrillation, which is an abnormal heart rhythm that begins in the top chambers of the heart. Electrical stimulation will be delivered to the wrists or in the ear. Participation will last about 6 weeks and require 3 clinic visits. Participants will be asked to wear a heart monitor and patch to monitor the heart rate and rhythm, keep a diary to collect information on atrial fibrillation, undergo randomization (being randomly assigned, like drawing straws) and use the study device per randomization assignment. Participants are randomized in a 1:1:1 fashion to a wrist worn study device, an ear piece study device or a sham wrist worn study device. A sham device looks like the real wrist worn device but does not deliver any electrical stimulation.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Date Added
January 10th, 2023
PRO Number
Pro00125124
Researcher
Charlie Strange

List of Studies


Keywords
Pulmonary
Summary

This study will evaluate the safety and effectiveness of fazirsiran (investigational drug) compared with placebo (an inactive substance) in patients with alpha-1 antitrypsin deficiency associated liver disease (AATD-LD). If eligible, subjects will be randomized (assigned to a group by chance) to receive either fazirsiran or placebo to be administered subcutaneously (an injection under the skin). Subjects will be treated on Day 1, at Week 4, and then every 12 weeks for 196 weeks. Subjects will be followed for 6 months after their last dose of study drug or placebo for a total study duration of approximately 230 weeks (including 10 weeks of the screening period which is the time needed to assess if a subject is eligible for the study).

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8438
blantonm@musc.edu

An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

Date Added
January 5th, 2023
PRO Number
Pro00125928
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

Following the study Entry Visit, subjects will return at Week 4,
Week 12, and every 12 weeks thereafter. Study visits will continue
for up to 6 years or until the subject prematurely discontinues study
treatment due to an adverse event or other reason, inhaled treprostinil
becomes commercially available for IPF in the region in which the
study is conducted, or the study is discontinued by the Sponsor
(whichever is sooner). Subjects will also be contacted by telephone or
email at least weekly until Week 12 and monthly thereafter in
between study visits to discuss study drug titration, assess study drug
tolerability, monitor adverse event, document changes to concomitant
medications, and remind subjects to bring in all study drug and a
device to their next clinic visit.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Non-cigarette tobacco products as harm reduction tools in smokers who failed to quit with traditional methods

Date Added
January 3rd, 2023
PRO Number
Pro00125514
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Institution
MUSC
Recruitment Contact
J'Neice Hunter
843-876-2291
paynejne@musc.edu

Synchronized cervical or transcranial auricular Vagus Nerve Stimulation (taVNS) with prefrontal repetitive transcranial magnetic stimulation (rTMS) for treatment resistant depression (TRD)

Date Added
January 3rd, 2023
PRO Number
Pro00125468
Researcher
Mark George

List of Studies


Keywords
Depression
Summary

The purpose of the research is to test out a combined treatment for depression where we stimulate a nerve in the ear while at the same time stimulating the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For patients who already have a cervical VNS device, we will not change their treatment and will use this in place of the taVNS. We think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, patients will have a screening session and then will have 6 treatment days total where they will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment they start with will be randomized, and they will have 2 treatment days of each combination.

Institution
MUSC
Recruitment Contact
Noah Vieira
843 2222889
vieira@musc.edu



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