Measuring Consciousness From Theory to Practice: Nuts and Bolts Save

Date Added
June 7th, 2016
PRO Number
Pro00054195
Researcher
Mark George
Keywords
Brain, Psychiatry
Summary

We will study healthy adults with a brain stimulation tool (TMS) either inside or outside of the MRI scanner, and test with EEG whether it matters where we place the TMS coil on the head. The TMS induced changes in EEG have been proposed as a surrogate measure of brain connectedness, which changes greatly when we are conscious and when we are not.

Institution
MUSC
Recruitment Contact
Sarah Hamilton
843-876-5141
hamilsar@musc.edu

Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression Save

Date Added
May 3rd, 2016
PRO Number
Pro00054689
Researcher
Julianne Hellmuth
Keywords
Alcohol, Drug Studies, Healthy Volunteer Studies, Mental Health, Psychiatry
Summary

Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin?s effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-792-2522
beylott@musc.edu

ESKETINTRD3004: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression Save

Date Added
January 26th, 2016
PRO Number
Pro00047444
Researcher
Robert Malcolm
Keywords
Depression, Drug Studies, Mental Health, Psychiatry
Summary

Major depressive disorder is a common, severe, chronic and often life-threatening illness. It is now the leading cause of disability worldwide. There is a clear need to develop novel and improved therapeutics for treatment-resistant major depression.

Studies with esketamine have shown robust antidepressant effects in several clinical studies and it has been well tolerated in these clinical studies.
The main purpose of this study is to assess the long-term safety, tolerability, and effectiveness of esketamine nasal spray plus a newly initiated oral (taken by mouth) antidepressant in patients with treatment-resistant depression.

All patients in this 60 week study will be treated with esketamine nasal spray plus a new oral anti-depressant. The new oral anti-depressant will be one of the following approved and marketed oral antidepressants: duloxetine (Cymbalta), escitalopram (Lexapro), sertraline (Zoloft), or venlafaxine extended release (Effexor XR).

Institution
MUSC
Recruitment Contact
Melissa Michel
843-792-1901
michelm@musc.edu

The Effects of Theta-Burst Stimulation Duration on Human Motor Cortex Excitability Save

Date Added
January 5th, 2016
PRO Number
Pro00051031
Researcher
Colleen Hanlon
Keywords
Psychiatry
Summary

Currently there is an interest in optimizing rTMS protocols and in particular theta burst stimulation as both a therapeutic and investigational research tool. In a recent publication by Gamboa et al. 2010 it was shown that extended theta-burst stimulation duration (80 seconds) might have reverse effects on cortical excitability when compared to the original Huang et al. 2005 publication (40 seconds). While the post treatment effects of the original Huang et al. 2005 protocol were successfully replicated, when cTBS protocols were doubled to 1200 pulses over 80 seconds and the iTBS protocols were doubled to 1200 pulses over 390 seconds, there was increased facilitation after the prolonged cTBS and decreased excitability after prolonged iTBS. In Hanlon et al. 2015 a novel theta burst paradigm (5 minutes) is described in which two trains of 1800 pulses of cTBS, separated by a one-minute interval. This study aims to replicate the findings of the Gamboa and Huang protocols as well as investigate how novel theta burst stimulation paradigms such as those described in Hanlon et al. 2015, which are currently being explored as therapeutic methods in addiction change cortical excitability.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-2335
lenchd@musc.edu

Interaction of Depression and Sensorimotor Function: An observational study of neural connectivity following treatment for depression Save

Date Added
December 2nd, 2015
PRO Number
Pro00049197
Researcher
Colleen Hanlon
Keywords
Depression, Psychiatry
Summary

This study seeks to recruit individuals who are scheduled to undergo non-invasive brain stimulation as a treatment for depression. Participants will be recruited through the Brain Stimulation Division in the Institute of Psychiatry at the Medical University of South Carolina. Following enrollment participants will be given a battery of senrorimotor assessments and an MRI scan before they begin brain stimulation treatment and within a week after they end their treatment. The goal of this study is to evaluate the impact of depression on sensorimotor function and the integrity of neural circuits involved in motor control.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-5732
lenchd@musc.edu

10 days of medial prefrontal cortex theta burst stimulation (MPFC cTBS) as a tool to improve clinical outcomes and decrease frontal-striatal reactivity to cues among treatment-engaged cocaine users Save

Date Added
October 6th, 2015
PRO Number
Pro00046438
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Substance Use
Summary

The goal of this pilot study is to determine if, in treatment-seeking substance dependent individuals, ten sessions of continuous theta burst transcranial magnetic brain stimulation (cTBS) over a brain region involved in craving (medial prefrontal cortex) can lower an individual's craving and brain response to drug-related cues. This study involves a screening visit, followed by one MRI visit, followed by ten cTBS treatment visits on consecutive days. There will be three follow-up MRI visits: the first will immediately follow completion of a 28-day outpatient treatment program, while the second and third will be one month and two months post-treatment.

Institution
MUSC
Recruitment Contact
Oliver Mithoefer
843-792-6402
mithoefe@musc.edu

Effect of approach bias modification on cue-reactivity in individuals with cannabis use disorder. Save

Date Added
October 6th, 2015
PRO Number
Pro00048215
Researcher
Brian Sherman
Keywords
Drug Studies, Psychiatry, Substance Use
Summary

Biases in cognitive processing of drug-related stimuli are central to the maintenance of addiction and contribute to poor treatment outcome. This study will evaluate how people who frequently use marijuana respond to marijuana cues, and if a computerized task affects this response. During the two week study period participants will engage in four computer task sessions, and response to marijuana cues will be assessed directly before and after the two-week study period. Two weeks after the last study visit, marijuana cue response and computer task performance will again be assessed. Marijuana use will be tracked throughout the study and follow-up periods.

You may be eligible if you:
Are between the ages of 18 and 65.
Smoke marijuana.
Are willing to provide informed consent.

Eligible participants may receive compensation.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

Marijuana Approach Bias Retraining and Neural Response in Youth Save

Date Added
June 2nd, 2015
PRO Number
Pro00044583
Researcher
Lindsay Squeglia
Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

Marijuana use during adolescence is problematic and has long-term negative social, academic, and health consequences. Decreasing substance use at this early stage could have significant long-term benefits; however, efforts to prevent or decrease marijuana use during adolescence have only been modestly effective. This study will examine the brains of youth (ages 16-21) using magnetic resonance imaging (MRI) before and after a brief computerized training created to possibly decrease marijuana use. Each participant will receive two brain scans, one before and one after 3 weeks (6 sessions) of active or sham computerized treatment, and participants will be followed for a year to track post-intervention substance use. No medications are involved in this study.
You/your child could be eligible to participate if he or she is:
Between the ages of 16 and 21.
Has or has not used marijuana.
Participants must provide informed consent and youth under 18 must have parental consent to participate.
Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Lindsay Meredith
843-792-1017
meredith@musc.edu

Theta Burst TMS as a Tool to Change Smoking Behavior Save

Date Added
May 5th, 2015
PRO Number
Pro00042165
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Smoking
Summary

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

Institution
MUSC
Recruitment Contact
Oliver Mithoefer
843-792-6402
mithoefe@musc.edu

rTMS as a Tool to Decrease Pain and Opiate Craving Save

Date Added
April 7th, 2015
PRO Number
Pro00042186
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for opiate dependence addiction. Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether rTMS over the prefrontal cortex can produce a reduction in your perception of pain, your desire to use opiates, and your brain?s response to opiate cues. TMS has been approved by the FDA as an investigational tool as well a therapy for depression.

Institution
MUSC
Recruitment Contact
Oliver Mithoefer
843-792-6402
mithoefe@musc.edu

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