Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement

Date Added
May 16th, 2023
PRO Number
Pro00126436
Researcher
Parneet Grewal

List of Studies

Keywords
Depression, Memory Loss, Stroke, Stroke Recovery
Summary

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
mcteague@musc.edu

A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)

Date Added
May 23rd, 2023
PRO Number
Pro00128352
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The FLEX study is a randomized, blinded, and placebo-controlled study assessing the efficacy and safety of an investigational drug for adults diagnosed with Generalized Myasthenia Gravis (gGM). The injectable investigational drug is being evaluated over a 12-week induction period and a 12-week maintenance period. Based on completion of these periods and a participant's response to the investigational injection, participants may qualify to continue in a 52-week extension study of the investigational drug. If you choose to enter this study, you will participate in the study for up to approximately 84 weeks (1 ½ years) and you will be asked to attend up to 34 study visits; visits can last from 1 to 4 hours.

It is unknown at this time whether the study treatment will improve participant's health. The potential risks of this study include the possibility of infections, low albumin levels, and increases in blood cholesterol.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
May 23rd, 2023
PRO Number
Pro00128438
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A randomized, double-blind, double-dummy, parallel group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib

Date Added
June 13th, 2023
PRO Number
Pro00128476
Researcher
Andrew Keegan

List of Studies

Keywords
Multiple Sclerosis
Summary

The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer Multiple Sclerosis relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio). Teriflunomide is an approved medication for the treatment of relapsing MS. This clinical study will have two parts. The first part is the masked part in which neither you nor your doctor know if you receive remibrutinib or teriflunomide and will last up for a maximum of up to 30 months (~2.5 years). This is followed by an Extension Part which will have treatment and safety follow up periods; during the treatment period remibrutinib treatment is provided to all participants who had completed core part of study for a maximum of up to 5 years.

Institution
MUSC
Recruitment Contact
Alison Line
Alison Line
line@musc.edu

Impact of capturing ictal events with ultra-long-term ambulatory EEG monitoring with REMI.

Date Added
June 27th, 2023
PRO Number
Pro00129426
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This study is being done to understand whether a different type of electroencephalography (EEG) monitoring that permits longer monitoring is able to capture more seizures than regular EEG monitoring, and whether this new type of monitoring will improve clinical care. This type of EEG monitoring (REMI) is currently cleared by the United States Government Food and Drug Administration (or FDA) for use in hospitals but not yet cleared to be used at home.
Eligible subjects who have EEG monitoring scheduled with either a 3-day EEG monitoring performed at home or with a 3-day EEG monitoring schedule at the Medical University of South Carolina (MUSC). Subjects are in the study for approximately 4 weeks and will need to come to the study center for one or two visits. They will be asked to wear 4 of Epitel's REMI Sensors on their head, in addition to the regular EEG electrodes, for two 2-week REMI EEG monitoring periods. A 2nd visit (clinic visit) at MUSC may be needed if the recording is at MUSC, in order to start the second REMI EEG monitoring session.
At the end of the study, three independent epileptologists will review the REMI EEG recordings and compile a report of any findings. They will then provide this report to the subject's neurologist who will assess the value of the additional EEG information, and save the report within the MUSC medical record.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Confidence Optimization through Resources for Education, Engagement, and Empowerment (CORE) Study

Date Added
June 29th, 2023
PRO Number
Pro00128946
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

This research study is being conducted to gather information about patients with inflammatory bowel disease (IBD) to better understand their knowledge and preferences about self-help resources and learn how to help patients better manage their disease. Participation in this study will involve signing a research consent form, completing questionnaires, and the opportunity to participate in self-help resources. Some participants may be offered the opportunity to participate in a virtual focus group, as well. Participation in the study will last approximately 3 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Date Added
July 5th, 2023
PRO Number
Pro00128818
Researcher
Bashar Badran

List of Studies


Keywords
Brain, Rare Diseases
Summary

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. hEDS patients have limited treatment options for their numerous symptoms that impact the quality of life. This clinical trial tests a new ear stimulation method in hEDS patients to determine if it may improve quality of life.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@musc.edu

Thrombophilia in Embolic stroke of undetermined source (ESUS)

Date Added
July 27th, 2023
PRO Number
Pro00127326
Researcher
Ghada Mohamed

List of Studies

Keywords
Brain
Summary

The purpose of this research study is to study the utility of advanced blood testing for patients who have had a stroke and tend to form blood clots more than usual. The study involves blood tests using a new testing system that may detect issues with blood clotting easier than conventional tests. This is a 12-month study and will involve one blood draw and follow-up phone calls

Institution
MUSC
Recruitment Contact
There is no research coordinator
3134180214
mohamedg@musc.edu

A Phase 0 Master Protocol Using the CIVO Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies

Date Added
August 22nd, 2023
PRO Number
Pro00128477
Researcher
Jason Newman

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This research is being done to better understand how anti-cancer drugs affect cells within a tumor. Injecting very small amounts (microdoses) of pembrolizumab alone or in combination with MK-0482 or MK-4830 above may help the developer of these drugs to understand more about how these drugs work and what changes they make on the tumor. Subjects in this study will have their tumor injected with anti-cancer drugs using a CIVO device. The CIVO device delivers microdoses of multiple drugs or drug combinations directly into the tumor. Some of the procedures in this study include ultrasound assisted placement for tumor injection, a mucrodose injection of anti-cancer drugs into the tumor, and surgery to remove the tumor. Participation in the study will take 5 visits over a period if 56 days. The screening portion will be 28 days and the treatment portion will be 28 days from the time of the injection to the time of follow-up contact by the study team.

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

A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD)

Date Added
August 28th, 2023
PRO Number
Pro00127713
Researcher
McLeod Gwynette

List of Studies


Keywords
Autism
Summary

Pimavanserin is an antipsychotic may have some beneficial effects on core autism symptoms and co-morbid conditions such as irritability, anxiety, sleep disorders, mood instability due to epilepsy, etc.). These potential benefits stem from pimavanserin's impact on the serotonin system in the body. This study will investigate pimavanserin in the treatment of irritability, core autism symptoms, and co-morbid conditions in children ages 6-17 years old.

Institution
MUSC
Recruitment Contact
McLeod Gwynette
843-792-4113
gwynette@musc.edu



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