Clinical and laboratory studies to determine the causes of neurological disease in adults and children

Date Added
September 15th, 2020
PRO Number
Pro00102718
Researcher
Catherine Ziats

List of Studies

Keywords
Alzheimers, Autism, Dementia, Epilepsy, Mental Health, Multiple Sclerosis, Parkinsons
Summary

Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.

A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.

Institution
Self Regional
Recruitment Contact
Catherine Ziats
8642507944
cziats@ggc.org

Food Allergy Symptom Self-management with Technology (FASST) for Caregivers: An mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children with Newly Diagnosed Food Allergy (Phase 2)

Date Added
July 21st, 2020
PRO Number
Pro00100789
Researcher
Brantlee Broome

List of Studies

Keywords
Allergy, Autoimmune disease, Education, Mental Health
Summary

The purpose of this study is to evaluate use of a mobile application (also commonly referred to as an app) designed to support caregivers of children with newly diagnosed food allergy. This study has 2 phases. In Phase 1, the researchers obtained feedback regarding use of mobile apps from caregivers who have been managing their child's food allergy for one year or more. The researchers then used this feedback to build a mobile app for caregivers of children with newly diagnosed food allergy. In Phase 2, the researchers will evaluate the mobile app during a 4-week evaluation period with a group of caregivers of children newly diagnosed with food allergy. The data obtained from this study will hopefully benefit caregivers of children with newly diagnosed food allergy.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843-735-9215
prenticm@musc.edu

A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy with Sertraline in the Treatment of Adults with Post-traumatic Stress Disorder

Date Added
June 22nd, 2020
PRO Number
Pro00096374
Researcher
Kathleen Brady

List of Studies

Keywords
Mental Health
Summary

Brexpiprazole is a medication being studied as a possible adjunctive (add- on therapy) treatment for post-traumatic stress disorder (PTSD) It was first approved in the United States (10 July 2015) for the treatment of schizophrenia and as an adjunctive therapy (add-on therapy) to antidepressants for the treatment of major depressive disorder. The reason for this study is to find out about the potential benefits and safety of brexpiprazole.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Integration of Prolonged Exposure (PE) and Coping Long-Term with Active Suicide Program (CLASP) for PTSD and Suicide Risk in Military Families

Date Added
April 7th, 2020
PRO Number
Pro00098186
Researcher
Anouk Grubaugh

List of Studies

Keywords
Mental Health, Military, Psychiatry
Summary

The purpose of this study is to see whether an integrated treatment for trauma survivors who are thinking about suicide called Prolonged Exposure and Coping Long Term with Active Suicide Program ("CLASP-PE") helps to reduce distress and improve safety. Participants will be asked to attend up to 16 therapy sessions held once or twice each week and complete questionnaires about mood and anxiety levels four times (before treatment, after treatment, and at 3- and 5-month follow-up. Study participation will last 5-6 months (weekly for up to 16 weeks and then once for assessments at 3 and 5 months).

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Targeting Parenting to Prevent HIV and Substance Use Among Trauma-Exposed Youth: A Mixed-Methods Needs Assessment

Date Added
March 16th, 2020
PRO Number
Pro00096161
Researcher
Nada Goodrum

List of Studies

Keywords
Adolescents, Alcohol, HIV / AIDS, Mental Health, Psychiatry, Sexually Transmitted Infections (STI), Substance Use
Summary

Many adolescents experience traumatic events, such as child abuse, physical or sexual assault, or witnessing violence. Teens who experience trauma are more likely to have problems with substance use and risky sexual activity. We want to understand how parents can support their teens and help keep them safe after traumatic events.

Institution
MUSC
Recruitment Contact
Nada Goodrum
843-792-8067
goodrumn@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

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

Intelligent Biometrics to Optimize Prolonged Exposure for PTSD- Clinical Trial

Date Added
January 7th, 2020
PRO Number
Pro00094890
Researcher
Sudie Back

List of Studies

Keywords
Mental Health, Military, Psychiatry, Stress Disorders
Summary

Posttraumatic stress disorder (PTSD) is a debilitating mental health condition that increases suicide risk and affects up to 20% of military veterans and 8% of the general population. Prolonged Exposure (PE) is an effective and proven form of talk therapy for PTSD. However, dropout rates are high (25-30%) and an estimated one-third of patients who complete PE still report symptoms of PTSD at the end of treatment. This study directly addresses these limitations by using a clinical trial to evaluate the ability of an innovative technology system to improve Prolonged Exposure (PE) therapy for veterans with PTSD.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Spectral correlates of impulsivity in patients with traumatic brain injury: A study of the effect of transcranial electrical stimulation of the ventrolateral prefrontal cortex on response inhibition

Date Added
November 19th, 2019
PRO Number
Pro00093356
Researcher
Nathan Rowland

List of Studies

Keywords
Brain, Mental Health, Psychiatry, Rehabilitation Studies
Summary

Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, we will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, we will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.

Institution
MUSC
Recruitment Contact
Dominika Pullmann
843-329-9777
pullmann@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



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