Integrating corticospinal tract assessment via sTMS and taVNS-augmented CIMT in infants with hemiplegia

Date Added
September 2nd, 2025
PRO Number
Pro00146198
Researcher
Dorothea Jenkins

List of Studies


Keywords
Brain, Central Nervous System, Infant, Pediatrics, Physical Therapy, Rehabilitation Studies, Stroke Recovery
Summary

Newborns who are born premature or infants who suffer brain injury are at risk for motor problems. The common motor skills of reaching and grasping that infants have to learn can be weaker on one side of the body, depending on the site of the brain injury. These skills are routinely practiced with an occupational therapist once or twice a week, to help the infant strengthen these skills. A high intensity therapy program of constraint induced movement therapy (CIMT) may be available for the infant, but it takes from 40-120 hours total treatment time for most infants to improve their motor skills.
Transcutaneous auricular vagus nerve stimulation (taVNS) stimulates a branch of a major nerve by the ear, called the vagus nerve, that may help improve your child's ability to learn motor skills. CIMT involves placing a soft mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions. By using both CIMT and the nerve stimulation together, we hope your child's movement skills will improve more than with therapy alone.
The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with the minimal amount of CIMT and whether a measure of the strength of the brain circuit to the arm and hand muscles can tell us how well a child may respond to this therapy.

Institution
MUSC
Recruitment Contact
Dorothea Jenkins
843-792-2112
jenkd@musc.edu

Open Pilot Trial of an Integrated Intervention for PTSD/AUD Symptoms Following Recent Trauma

Date Added
September 2nd, 2025
PRO Number
Pro00146740
Researcher
Christine Hahn

List of Studies


Keywords
Women's Health
Summary

This study is for people who have experienced a traumatic event in the past one year and drink alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete a interview about their experiences.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

Exploring Caregiving Choice in the Adult Cancer Population: A Multi-Method Study

Date Added
September 9th, 2025
PRO Number
Pro00145673
Researcher
Jennifer Huggins

List of Studies

Keywords
Cancer, Non-interventional
Summary

Using surveys researchers will assess caregiver choice, caregiver quality of life (CQOL), caregiver sleep, caregiver stress, and caregiver burden (CB). Some participants answering surveys (approximately 20), will be chosen by researchers to participate in an interview to gain a deeper understanding of the perspectives of individuals who assume caregiving responsibilities without a personal sense of choice.

Institution
MUSC
Recruitment Contact
Jennifer Huggins
854.429.2454
hugginje@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (ZION)

Date Added
September 9th, 2025
PRO Number
Pro00145511
Researcher
Charlie Strange

List of Studies


Keywords
Breathing, Inflammation, Pulmonary, Shortness of Breath
Summary

Solrikitug is an investigational drug, a drug that is still in development and testing, that can potentially benefit individuals with chronic obstructive pulmonary disease (COPD) by the pathway that causes type 2 inflammation. Solrikitug is given as an injection in the arm. Eligible participants will be randomized to receive a single dose of study medication (Solrikitug 375mg), three doses (day 1, week 4 and week 8) or placebo (inactive drug). The study is double blinded so neither the treatment team nor the participant will know what drug treatment they received. Enrollment in the study is up to 32 weeks, 4 weeks for screening and 28 weeks for treatment and follow up. Assessments conducted at the study visits include, but are not limited to, medical history and medication review, physical exams, blood tests, EKGs to look at the heart, breathing tests and questionnaires.

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

BTX-302-001: A Phase 1/2 dose-exploration and dose-expansion study to evaluate the safety and efficacy of BEAM-302 in adult patients with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung disease and/or liver disease.

Date Added
September 9th, 2025
PRO Number
Pro00146485
Researcher
Charlie Strange

List of Studies


Keywords
Genetics, Liver, Lung, Pulmonary, Rare Diseases
Summary

BTX-302-001 is a research study investigating the safety (how many side effects participants may have) and tolerability (how tolerable the side effects are) of BEAM-302 for individuals with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung and/or liver disease. This study also aims to gather additional information regarding how BEAM-302 moves through the participant's body, how long it stays, and how long it takes to eliminate it - which is defined as the study drug's pharmacokinetics or "PK". Researchers would like to determine through this research study how BEAM-302 impacts the disease course (progression) of AATD in terms of AATD blood biomarkers, which are substances in blood that the body normally makes and will help show if an individual's AATD is improving, staying the same, or getting worse, along with lung and liver function testing results and the quality of life of participants.

This research study will be split into two main parts, Part A (which is for individuals with AATD-associated lung disease with no clear evidence of AATD-associated liver disease) and Part B (which is for individuals with AATD-associated liver disease). Additionally, each Part will be split into two separate cohorts, where one cohort will receive a single intravenous (IV) infusion of BEAM-302 (single-dose cohort) and the other will receive two IV infusions of BEAM-302 approximately 8 weeks apart (multi-dose cohort). Within these cohorts (single-dose and multi-dose), there are also separate smaller cohorts that will vary by the dose of BEAM-302 administered to participants, so a participant in this study could receive any of the following dosages - 15mg, 30mg, 60mg, 75mg, or 90mg. Overall, the research study will last up to around 29 months for each participant, depending on which cohort they are in, and their participation will be split into three main study periods - Screening, Dose and Dose-limiting toxicity (DLT), and Follow-up. It is also important to note that when a participant is receives their infusion(s) of BEAM-302 during the Dose and DLT period, the administration of the study drug will be done as a part of an in-patient hospital stay that will last up to 48 hours so that they can be closely monitored by the study team.

The key eligibility criteria for this study are that individuals (male or female) must be 18 to 70 years old, possess the PiZZ type of AATD, and have either AATD-associated lung disease with no clear evidence of AATD-associated liver disease or AATD-associated liver disease. There are additional eligibility criteria that must be met in order to be able to participate in the study, which will be assessed across up to 2 study visits that will occur during the Screening period.

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8432
blantonm@musc.edu

A randomized controlled trial of transcutaneous electrical nerve stimulation for pain mitigation during intrauterine device placement

Date Added
September 16th, 2025
PRO Number
Pro00143776
Researcher
Michelle Meglin

List of Studies


Keywords
Obstetrics and Gynecology
Summary

We are conducting this study to determine whether using a TENS (nerve stimulation) unit is effective at reducing pain in women having an IUD inserted.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

A Randomized Phase III Trial of Checkpoint blockade in Lung cancEr patients in the Adjuvant setting based on pathologic Response following neoadjuvant therapy (CLEAR)

Date Added
September 26th, 2025
PRO Number
Pro00146815
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer/Lung
Summary

This phase III trial compares the effect of adding AZD6738 to durvalumab versus durvalumab alone to increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery. AZD6738 may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Adding AZD6738 to durvalumab may increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery.

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

Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study

Date Added
October 7th, 2025
PRO Number
Pro00146983
Researcher
Mark George

List of Studies


Keywords
Depression, Nervous System
Summary

In this study, we are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp.

The study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. We will check skin comfort, mood, and overall tolerability after each session.

Institution
MUSC
Recruitment Contact
Clayton Olash
843-243-7305
olash@musc.edu

A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients with Chronic Mucus Hypersecretion

Date Added
October 14th, 2025
PRO Number
Pro00147345
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung
Summary

This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).

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

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria

Date Added
October 23rd, 2025
PRO Number
Pro00145633
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Autoimmune disease, Skin
Summary

The purpose of this study is evaluate safety and effectiveness of an investigational drug in adults diagnosed with chronic urticaria (hives). The investigational drug is known as BLU-808 and will be taken daily orally. Participation in the study is expected to be approximately 18 weeks.

Institution
MUSC
Recruitment Contact
Emma McLeod
843-792-8008
mcleodem@musc.edu



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