Testing a wearable telemedicine-controllable taVNS device for NeuroCovid Recovery and Rehab

Date Added
September 1st, 2020
PRO Number
Pro00101270
Researcher
Mark George

List of Studies

Keywords
Anxiety, Coronavirus, Depression, Pain
Summary

The purpose of the research is to test out a new form of treatment where we stimulate a nerve in your ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that you will receive stimulation through the ear. The taVNS device looks like an ear bud you would use with your smart phone or computer. We are investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms you may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.

Institution
MUSC
Recruitment Contact
Sarah Huffman
843 8765141
huffmans@musc.edu

RECOVER: A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Date Added
March 10th, 2020
PRO Number
Pro00095951
Researcher
Mark George

List of Studies

Keywords
Depression, Mental Health, Psychiatry
Summary

Depression is a very common disorder that is most often chronic or recurrent in nature. Many subjects do not respond adequately to an initial antidepressant treatment trial. Subjects who do not respond adequately to multiple therapeutic interventions are considered to have treatment-resistant depression (TRD). Among the treatment options for subjects with TRD is Vagus Nerve Stimulation (VNS) Therapy.This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Initial Intervention Efficacy, Cortisol, and Oxytocin among Pregnant Women with PTSD

Date Added
February 11th, 2020
PRO Number
Pro00096405
Researcher
Mary Shapiro

List of Studies

Keywords
Anxiety, Depression, Pregnancy, Women's Health
Summary

The current study aims to adapt and test a brief computer-assisted intervention for pregnant women with elevated posttraumatic stress symptoms. Twenty pregnant women in their first trimester will be invited to participate in the study if they endorse elevated posttraumatic stress symptoms. Along with self-report measures, hormones will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery. In addition, women will receive a psychoeducation + skills intervention during their first trimester and women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.

Institution
MUSC
Recruitment Contact
Mary Shapiro
843-792-0259
shapimar@musc.edu

Depression and Attentional Bias

Date Added
January 29th, 2020
PRO Number
Pro00087075
Researcher
Jared Woodward

List of Studies

Keywords
Brain, Central Nervous System, Depression, Psychiatry
Summary

The purpose of this research study is to determine if there is a difference in the way that people pay attention to their surroundings when they are depressed. This can be tested by using a line bisection test, where people with and without depression are asked to divide a line in half. We have hypothesized that people with depression, who are more self-reflective, will demonstrate a downward preference when they perform the line bisection test compared to people without depression.

Institution
MUSC
Recruitment Contact
Jared Woodward
843-697-5638
woodwarj@musc.edu

CBT-I Targeting Co-morbid Insomnia in Patients Receiving rTMS for Treatment-Resistant Major Depressive Disorder

Date Added
January 22nd, 2020
PRO Number
Pro00089725
Researcher
Michael Norred

List of Studies

Keywords
Depression, Mental Health, Psychiatry, Sleep Disorders
Summary

Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). We will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.

Institution
MUSC
Recruitment Contact
Michael Norred
8438701181
norredm@musc.edu

Stressors of Inter-ICU Transfer: Family Centered Care through Telehealth

Date Added
December 2nd, 2019
PRO Number
Pro00092555
Researcher
Nandita Nadig

List of Studies

Keywords
Anxiety, Depression
Summary

The purpose of this research study is to reduce psychological distress and improve communication and family centeredness of care for families of Ventilator Dependent Respiratory Failure (VDRF) patients that have undergone inter-ICU transfer by providing them with timely and adequate information about their transfer of care. This will be accomplished by the development and refinement of our Stressors of Inter-ICU Transfer Telehealth Tool (SITT). The study aims to assess reactions to mocked up SITT domains and support resources of 15-20 family members that have undergone inter-ICU transfer as well as 10 clinicians involved in transfer. The data will drive the refinement of the tool to best meet the needs of the families and clinicians.

Institution
MUSC
Recruitment Contact
Kyle White
8437922297
whiteky@musc.edu

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Ketamine for the Treatment of Concurrent Opioid Use Disorder and Major Depressive Disorder

Date Added
November 5th, 2019
PRO Number
Pro00091292
Researcher
Jennifer Jones

List of Studies

Keywords
Depression, Mental Health, Psychiatry, Substance Use
Summary

The purpose of the study is to examine whether an investigational medication called ketamine, which comes in the form of a nasal spray, is able to improve treatment outcomes for concurrent opioid addiction and depression when used in conjunction with buprenorphine treatment. Study medications will be delivered twice per week for four weeks. If you are eligible and you decide to enroll in the study, your participation will last approximately 8 weeks, or 2 months.

Institution
MUSC
Recruitment Contact
Jennifer Jones
(843) 792-5594
jonjen@musc.edu

tDCS-Augmented Prolonged Exposure Therapy for PTSD: A Multiple Baseline Within-Subject Clinical Trial

Date Added
November 5th, 2019
PRO Number
Pro00093774
Researcher
Adam Cobb

List of Studies

Keywords
Depression, Mental Health, Military, Nervous System, Psychiatry, Stress Disorders, Substance Use
Summary

The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. tDCS has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. In this study, tDCS is provided in addition to PE treatment, through the National Crime Victim's Research and Treatment Center at MUSC, or the PTSD Clinical Team Clinic within the Ralph H. Johnson VA Medical Center.

Institution
MUSC
Recruitment Contact
Adam Cobb
843-792-7688
cobbad@musc.edu

Assessing Mental Health Resources in U.S. Trauma Centers for Families Affected by Pediatric Traumatic Injury

Date Added
September 27th, 2019
PRO Number
Pro00091869
Researcher
Leigh Ridings

List of Studies

Keywords
Children's Health, Depression, Mental Health, Pediatrics, Surgery
Summary

Pediatric traumatic injury (PTI) – defined as unintentional injury requiring hospitalization and, often, extended periods of physical and emotional recovery – is experienced by 300,000 children in the U.S. annually. Roughly 20-40% of children and caregivers develop posttraumatic stress disorder (PTSD) and/or depression following PTI, yet most U.S. trauma centers fail to provide even basic mental health screening post-injury. It is critical to advance our knowledge of available mental health services in trauma centers for this frequently overlooked population to accelerate their physical and emotional recovery. In this project, trauma center providers across the U.S. will complete a survey and a qualitative interview to assess their current protocols and resources available to screen and treat children and families' mental health in the aftermath of PTI, as well as their opinions regarding feasibility of implementing protocols to better address the emotional health recovery within this population.

Institution
MUSC
Recruitment Contact
Leigh Ridings
843-792-5146
ridingle@musc.edu

Managing AsThma AnD Obesity Related Symptoms (MATADORS) study: An mHealth intervention to facilitate symptom self-management among youth

Date Added
August 8th, 2019
PRO Number
Pro00090560
Researcher
Michelle Nichols

List of Studies

Keywords
Adolescents, Asthma, Children's Health, Depression, Obesity, Pain
Summary

Youth with one or more chronic diseases are at increased risk of further complications, disease, or even early death as they enter their adult years. Recent increases in both asthma and obesity among youth have led to high health care utilization, increased health-related complications, and expanded risks of subsequent cardiovascular disease burden. The research team will develop educational content in core areas (e.g., fatigue, physical activity) for Managing AsThma AnD Obesity Related Symptoms (MATADORS), an mHealth technology-enhanced nurse-guided intervention. Youth with asthma and obesity and their primary caregivers will participate in interviews to explore their perspectives on barriers, facilitators, needs, and preferences toward adopting health behaviors, medication adherence, disease awareness, symptom self-management behaviors, and utilization of a mobile smartphone platform. Additional details on content availability, delivery approaches, system needs, and functionality will be explored through semi-structured interview questions. Health care providers (physicians, nurses, nurse practitioners, dietitians, and respiratory and exercise therapists) will be invited to participate in interviews to seek their input on patient-caregiver needs, priority clinical focal areas, recommendations for symptom self-management, and preferences for intervention delivery. Interview findings will be used to inform intervention and app design. Providing youth with strategies to enhance symptom self-management may result in decreased symptom prevalence, improved quality of life, and long-term reduction of cardiovascular morbidity and mortality as they move into adulthood.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843-792-4771
prenticm@musc.edu



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