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

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
Joseph Chasen

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

Use of surgical tissue to characterize immune responses in cancer and inflammatory diseases using multi-omic approaches and patient-derived organoids

Date Added
August 28th, 2025
PRO Number
Pro00145021
Researcher
Silvia Guglietta

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This research study aims to better understand how the immune system functions in human diseases such as cancer and chronic inflammation. We will collect small amounts of tissue that are already being removed during routine surgeries, such as liver transplants or colorectal cancer resections. These tissues would otherwise be discarded. By studying immune cells and molecules within these samples, our team hopes to uncover how inflammation and immune signaling contribute to disease progression. The ultimate goal is to identify new ways to diagnose, monitor, or treat these conditions in the future. Participation does not involve any extra procedures or risk beyond the surgery already being performed.

Institution
MUSC
Recruitment Contact
Silvia Guglietta
(843) 792-9702
gugliett@musc.edu

A PHASE 1 / 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Date Added
August 28th, 2025
PRO Number
Pro00144472
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This study is the first time the drug PF-07868489 will be tested in humans. The goal is to see if the drug is safe and how the body reacts to it. In the first part, healthy adults will receive a single dose to check for any side effects and how the drug moves through the body. In the second part, patients with a specific lung condition called Pulmonary Arterial Hypertension (PAH) will receive multiple doses to see if the drug helps their condition and to further check its safety and effects.

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

E-Care Breast Cancer Risk Assessment Study

Date Added
August 27th, 2025
PRO Number
Pro00145415
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer/Breast, Women's Health
Summary

We will evaluate the ability of a technology-based intervention E-Care to improve communication of information about breast cancer risk and improve discussion about breast cancer screening in the primary care setting. Women ages 25-75 seen by their primary care clinician are potentially eligible to participate. Study activities include completion of a health questionnaire, reviewing a video on breast cancer screening, completion of a post-visit survey, and potential opportunity for a brief interview.

Institution
MUSC
Recruitment Contact
Mattie Banks
843-876-2926
banksmat@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

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu



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