Probing mechanisms of procedural memory transformation with cross-frequency transcranial alternating current stimulation (cf-tACS) as an avenue to sculpt sensorimotor behavior

Date Added
March 7th, 2023
PRO Number
Pro00126392
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Aging, Central Nervous System, Healthy Volunteer Studies, Memory Loss
Summary

Sometimes, it is necessary to re-learn a previously learned movement behavior, for example, a bad posture during the golf drive or while playing the piano. Unlearning or relearning an intensively trained behavior is particularly important if the behavior is hampering recovery, for example, in chronic pain or after a stroke. With this study, we experimentally test the brain mechanisms that control the change of pre-existing stable memories of a motor skill with electroencephalography (EEG). We will then use non-invasive brain stimulation to modulate these brain mechanisms and test if it is possible to change the pre-existing motor memory and the learning of a new motor skill.

Institution
MUSC
Recruitment Contact
Valerie Salisbury
843-792-6150
iNRLab@musc.onmicrosoft.com

Ketamine-assisted Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder

Date Added
March 7th, 2023
PRO Number
Pro00126022
Researcher
Emily Amador

List of Studies

Keywords
Drug Studies, Smoking
Summary

The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for tobacco use disorder when delivered in conjunction with brief motivational enhancement therapy. Subjects will receive ketamine assisted motivational enhancement therapy weekly for three weeks. If you are eligible and you decide to enroll in the study, your overall participation will last approximately 8 weeks.

Institution
MUSC
Recruitment Contact
Emily Amador
843-906-6171
amador@musc.edu

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Date Added
March 16th, 2023
PRO Number
Pro00125361
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The primary objective of this study is to determine how bictegravir (BIC) plus lenacapvir (LEN) in two different doses affects an HIV-1 infection in the body compared with current standard treatment regimens. Other objectives are to determine which of these treatments are the most effective for treating HIV-1 infection, the safety and tolerability of these two doses for people with HIV, as well as how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems experienced during the study.

Institution
MUSC
Recruitment Contact
Marion Campbell
843-792-8894
cammario@musc.edu

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab

Date Added
March 27th, 2023
PRO Number
Pro00118564
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). The investigational drug in this study is lurbinectedin. Investigational means it is not yet approved by the Food and Drug Administration (FDA). The purpose of this study is to compare the effects, good or bad, of lurbinectedin in combination with atezolizumab versus atezolizumab alone in participants with ES-SCLC. Atezolizumab is already approved for treatment of ES-SCLC.

There are two phases of treatment. During the induction phase of the treatment, participants will receive 4 cycles of carboplatin, etoposide, and atezolizumab. One treatment cycle is 3 weeks long. During the maintenance phase of the treatment, participants will be placed in one of the following treatment groups: Arm A will receive atezolizumab and lurbinectedin given as an infusion (into the vein) on Day 1 of each 21-day cycle; Arm B will receive atezolizumab given as an infusion (into the vein) on Day 1 of each 21-day cycle.

During this study, participants will have visits approximately every 3 weeks while receiving treatment. Visits may last 3-6 hours. After the final dose, the study doctor will follow up about every 3 months. The total time in the study will depend on how the ES-SCLC responds to treatment. This could range from 1 day to more than 4 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson's Disease

Date Added
March 28th, 2023
PRO Number
Pro00123124
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study will help determine the safety and effectiveness of BIIB122, compared to placebo (an inactive substance), in people with early-stage Parkinson's disease. The use of BIIB122 in this study is investigational. "Investigational" means that the study drug is currently being tested and is not approved by the U.S. Food and Drug Administration (FDA) or any other health authorities around the world for treating people with PD. The study is expected to last a minimum of 1 year to a maximum of 3 years. You may or may not receive direct medical benefit from participating in this study. Your condition may get better, worse, or stay the same. The information obtained from this study, however, could help other patients with your disease in the future.

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
wilsosan@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

Tracking Brain Biomarkers and Renormalization Associated with Antidepressant Transcranial Magnetic Stimulation Therapy

Date Added
April 4th, 2023
PRO Number
Pro00127417
Researcher
Andrew Manett

List of Studies


Keywords
Brain, Depression
Summary

The purpose of this study is to use magnetic resonance imaging (MRI) to take images of a participant's brain, and then apply an investigational way of processing the image, called Individualized Network-based Single-frame Coactivation Pattern Estimation ("INSCAPE") to measure participant's brain activity. This method uses a computer program to understand which parts of the brain communicate with each other and creates a map of the brain areas that are connected.

Participants being recruited in this study will include people planning to receive Transcranial Magnetic Stimulation ("TMS") for Major Depressive Disorder ("MDD"). Healthy participants are also being recruited. Images taken of depressed participants' brains will be compared to images of non-depressed participants' brains. Participation in this study will require three visits in which you will undergo MRI scans. The interval between each visits is about 3 weeks. Depressed participants will also complete mood assessments at several different intervals while they are receiving TMS for depression.

During each visit, MRI scans will require about 30 minutes of time in total. During the MRI scan, participants will need to stay still, relax, and keep eyes open in the scanner.

Institution
MUSC
Recruitment Contact
Andrew Manett
843-792-5716
manett@musc.edu

An Electrophysiological Predictor of SSRI Response in Veterans with PTSD

Date Added
April 4th, 2023
PRO Number
Pro00124873
Researcher
Zhewu Wang

List of Studies


Keywords
Mental Health, Military, Psychiatry
Summary

By doing this study, we hope to learn if a brief screening method can predict which people are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. This brief screening method involves using electrodes attached to your scalp via a cap, to measure electrical brain activity in response to a series of loud tones.
Your participation in this research will last about 17-21 weeks if you decide to stay for the whole study.

Institution
MUSC
Recruitment Contact
Erica Cortes
843-829-2110 xt 1011
erica.cortes@va.gov

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

Date Added
April 6th, 2023
PRO Number
Pro00124137
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Liver
Summary

To evaluate the efficacy of an investigational medication (INT-787) as assessed by disease progression in severe alcohol-associated hepatitis (sAH).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu



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