Quantification of phosphorylated alpha-synuclein in patients with Parkinson's disease and REM sleep behavior disorder (Syn-Q)

Date Added
August 27th, 2025
PRO Number
Pro00143143
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study aims to study the natural progression of P-SYN quantification by conducting skin biopsies in patients with Parkinson's Disease (PD) and REM sleep behavior disorder (RBD). Participation will be over an 18-month period and will include skin biopsies and clinical examinations every six months. Subjects will be male or female between the ages of 50-100 and have a diagnosis of PD or RBD.

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

A Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair

Date Added
August 27th, 2025
PRO Number
Pro00145325
Researcher
Charles Daly

List of Studies

Keywords
Nerve, Surgery
Summary

The study is a 48-week clinical study to compare study medication NTX-001 used intraoperatively to promote nerve regeneration compared to the standard of care on surgery for acute nerve damage in the hand on subjects between the ages of 18 to 80 years old. Subjects who present with sever nerve damage of the hand and need surgery to repair the nerve damage within 48 hours of injury. After surgery, subjects will complete 12 total study visits: 6 in person and 6 additional telehealth visits. During the in-person clinic visits, subjects will be assessed by physical examinations, vital signs, safety laboratory assessment and complete questionnaires. Subjects with motor/mixed motor injury will also complete an EMG and NCV assessments with an Occupational Therapist at 2 of the in-person visits. During the telehealth visits, subjects will complete questionnaires.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Prospective changes in patient-reported and objective functioning following reduction of cannabis use

Date Added
September 2nd, 2025
PRO Number
Pro00145652
Researcher
Rachel Tomko

List of Studies


Keywords
Mental Health, Psychiatry, Substance Use
Summary

Adults (ages 18+) who use cannabis and are interested in reducing their use will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1- and 4-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Participants are also asked at different points throughout the study to wear a Fitbit to monitor their sleep.

Institution
MUSC
Recruitment Contact
Kevin Branson
843-792-0493
bransonk@musc.edu

Accelerated, Left Prefrontal Transcranial Magnetic Stimulation for Functional Seizures; An Open-Label Exploration of Feasibility, Tolerability, and Preliminary Efficacy

Date Added
September 2nd, 2025
PRO Number
Pro00144502
Researcher
Mark George

List of Studies


Keywords
Mental Health, Psychiatry
Summary

As growing research suggests noninvasive brain stimulation techniques have the potential to adjunct current treatments or treat Seizure-Type Functional Neurologic Disorder (FND-seiz), also known as Psychogenic Non-Epileptic Seizures (PNES), we aim to evaluate whether a form of accelerated intermittent theta burst transcranial magnetic stimulation (a-iTBS-rTMS), is a practical and well-tolerated treatment for people with this disorder. Transcranial Magnetic Stimulation or TMS uses magnetic pulses to stimulate a part of the brain involved in mood and thinking, the left dorsolateral prefrontal cortex, which has established benefits in disorders known to coincide in patients with FND-seiz, such as depression.

As an open-label, early feasibility study, enrolled participants will receive 6 to 10 treatment sessions each day over 3 to 5 days, with the goal of completing 30 total sessions. This approach was selected because similar protocols have already been shown to be safe and effective in other conditions, and the shortened treatment schedule in comparison to other protocols may make participation easier for people living with FND-seiz. The main goal of the study is to see how many participants can safely and comfortably complete at least 20 of the 30 TMS sessions.

The researchers will also evaluate changes in seizure frequency, quality of life, mood, post-traumatic stress symptoms, physical health, social functioning, and overall satisfaction with treatment. These outcomes will be measured before treatment and again four weeks afterward. The researchers also aim to explore whether people with overlapping conditions, such as depression or PTSD, respond differently to the treatment. Finally, given the overlap between epilepsy and FND-seiz, not all TMS providers are comfortable treating patients with FND-seiz when TMS is indicated for other conditions, thus the researchers aim to outline a protocol to ensure safety and increase TMS access for FND-seiz patients.

Institution
MUSC
Recruitment Contact
Joseph Chasen
(843) 637-1358
chasenj@musc.edu

TMS-iEEG Causal Mapping of Cognitive-Emotional Network Dynamics in Epilepsy

Date Added
September 2nd, 2025
PRO Number
Pro00146626
Researcher
Lisa McTeague

List of Studies


Keywords
Brain, Depression, Epilepsy, Mental Health, Psychiatry
Summary

Patients with drug-resistant epilepsy often experience problems with mood, thinking, or behavior that cannot be explained by seizure activity alone. This study will examine how cognitive and mood-related brain regions communicate in patients undergoing routine intracranial electroencephalogram (iEEG) seizure assessment in the Epilepsy Monitoring Unit at the Medical University of South Carolina (MUSC). While the clinical electrodes are in place, we will apply brief single magnetic pulses (single-pulse transcranial magnetic stimulation, or spTMS) to the scalp in specific brain regions and record the brain's electrical response through the existing electrodes; no additional surgery is required. We will compare the responses to stimulation of an emotionally and cognitively relevant region (left dorsolateral prefrontal cortex) with a contrast site (primary motor cortex). We will also investigate whether momentary brain rhythms and seizure-related electrical activity affect responses propagation through the brain. The findings may help identify measurable brain signaling patterns ("biomarkers") to understand how cognitive-emotional brain networks work in people with epilepsy and inform future personalized non-invasive brain stimulation methods for treating neurological and psychiatric disorders.

Institution
MUSC
Recruitment Contact
Corbin Ping
(843) 608-0329
pingc@musc.edu

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



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