The MOOD study – external Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the treatment of Major Depressive Disorder (MDD)

Date Added
October 20th, 2021
PRO Number
Pro00114373
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

The purpose of this research is to evaluate whether the Relivion®DP device is safe and helpful in alleviating Major Depressive Disorder (MDD) symptoms. The research study includes up to 6 visits, each visit could be performed either at the clinic or remotely using digital means such as a video call or the use of another dedicated platform.In this research study the participant will randomly receive either an active device or a non-active (sham) device and the participant will be asked to preform daily treatments with the device for 8 weeks after which the participant will have the option to continue to an additional 8 week open-label extension with the active device.
We expect that the time commitment for taking part in this research will last up to 20 weeks (including the screening period).

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

Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Generalized Anxiety Disorder

Date Added
July 6th, 2021
PRO Number
Pro00109178
Researcher
Mark George

List of Studies


Keywords
Anxiety
Summary

The purpose of this research is to test out a new way of treating generalized anxiety disorder (GAD) with low intensity focused ultrasound pulsation (LIFUP). If the subject agree to participate in the research study, the participation will last approximately 10.5 hours over seven (7) days. The visits are as follows: 1- consent and MRI, 2- and 3- focused ultrasound will be delivered outside of the MRI environment, 4- MRI plus focused ultrasound, 5- assessments 1 week post focused ultrasound, and 6- one month follow-up assessments. Research studies are voluntary and include only people who agree to take part.

Institution
MUSC
Recruitment Contact
Sarah Huffman
843-792-8672
huffmans@musc.edu

The International Randomized Controlled Trial of Two Forms of Electroconvulsive Therapy (ECT) for Severe Depression: Focal Electrically-Administered Seizure Therapy (FEAST) and Right Unilateral Ultrabrief (The iFEAST Study)

Date Added
June 2nd, 2020
PRO Number
Pro00098725
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

This is a research study to find out if a new form of electroconvulsive therapy (ECT) is as effective and safe as a current form. The new form of ECT is called FEAST which stands for Focal Electrically Administered Seizure Therapy. This new form uses different electrode placement on the head and a different way of delivering the electricity. FEAST will be administered with an investigational device in this clinical trial. If enrolled in this this study, participants will be randomly assigned (like flipping a coin) to receiving FEAST or the current standard form of ECT called Right Unilateral UltraBrief ECT (RUL UB).

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

Randomized controlled trial of EEG/fMRI Controlled TMS For Treating Depression

Date Added
February 6th, 2018
PRO Number
Pro00074695
Researcher
Mark George

List of Studies


Keywords
Depression
Summary

Currently rTMS for treating depression is delivered without knowing whether the TMS pulses are synchronized with the patient's brain rhythms. We have built a combined TMS/fMRI/EEG machine and have shown that delivering a TMS pulse over the prefrontal cortex precisely timed produces a bigger brain response. We now wonder if precisely timing the TMS pulses might enhance the antidepressant effects of TMS. We will randomize depressed patients to either the current standard of care, or the same TMS but precisely timed.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843 876 5142
maddoxm@musc.edu

Measuring Consciousness From Theory to Practice: Nuts and Bolts

Date Added
June 7th, 2016
PRO Number
Pro00054195
Researcher
Mark George

List of Studies


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

Determining the best dose of electroconvulsive therapy (ECT): comparing seizure threshold titration with two different fixed currents (600 mA vs. 900 mA)

Date Added
June 2nd, 2015
PRO Number
Pro00044575
Researcher
Mark George

List of Studies


Keywords
Depression
Summary

Over the past 30 years we have discovered that both the efficacy and the side effects of ECT come not only from the induced seizure, but by the currents of electricity and where they go in the brain. In all patients we now determine, at the first treatment session, the minimum dose of electricity needed to produce a seizure. This is called the seizure threshold. Subsequent treatments are then given at 6 or 9 times this number. The method of titrating has not been fully explored. We propose to titrate with two different currents, one of which is much lower than standard clinical practice. We need to do this twice in each patient, on the first and second treatment sessions, and compare the difference. If we find that that lower currents are paradoxically better, then this will change ECT practice around the world. Patients will receive less overall electricity, with likely fewer side effects.

Institution
MUSC
Recruitment Contact
John Henderson
843 876 5142
henderjs@musc.edu

EEG/fMRI Controlled TMS Real-time Neural Feedback in Anti-Depressive Treatment

Date Added
April 7th, 2015
PRO Number
Pro00042072
Researcher
Mark George

List of Studies


Keywords
Healthy Volunteer Studies, Mental Health
Summary

This study proposes to design and build a neural imager/stimulator which will let us obtain information about brain circuits and pathways by acquiring electrical and fMRI signals from the brain at the same time. By adding magnetic stimulation to the instrument we will be able to perturb these circuits at precise times and locations in order to both improve how TMS is used as an anti-depression treatment as well as to better understand how our brains function. This research has the potential to revolutionize our understanding of how best to use TMS as a treatment as well as learning how our brains function. This study simply proposes to develop the combined instrument. The use of the new instrument as a anti-depressive treatment will be presented independently after we have developed a working instrument.

Institution
MUSC
Recruitment Contact
Alana McMichael
843-876-2465
EEGTMSproject@musc.edu



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