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

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

A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD) Save

Date Added
June 27th, 2017
PRO Number
Pro00064375
Researcher
Mark George
Keywords
Depression, Military, Psychiatry, Stress Disorders
Summary

Objectives: The aim of the study is to evaluate the efficacy and safety of DTMS for the treatment of PTSD.
Patient Population: 176 male and female subjects, 22-68 years of age, currently diagnosed with PTSD according to the DSM-V criteria.
Structure: A randomized, controlled, prospective, 9 week, double blind, multicenter study.
Blinding: The treatment administrator, study rater, all study personnel and patients will be blinded to the treatment being administered.
Concurrent Control: The study group will receive active DTMS treatment and the control group will receive inactive, sham treatment.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843 577 5011 ext 5209
matthew.schmidt@va.gov

Optimization of ECT in the Treatment of Veterans with Co-morbid Major Depression and PTSD Save

Date Added
May 2nd, 2017
PRO Number
Pro00062581
Researcher
Mark George
Keywords
Depression, Military, Psychiatry
Summary

The purpose of this study is to determine if there are any differences in the improvement of MDD and PTSD symptoms when using two different types of ECT, and also to determine what effect recalling two different memories (a positive memory or negative PTSD memory) just prior to receiving ECT may have on PTSD symptoms. The two types of ECT treatment to be used in this study are called right unilateral ultrabrief (RUL UB) ECT and bilateral brief pulse (BL BP) ECT. Both types of ECT are widely used in the treatment of depression and are commonly used when ECT is recommended. This study will involve 70 (35 local and 35 at Long Beach VA site) subjects who are veterans suffering from MDD and PTSD.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843-577-5011 ext 5209
NA

A Prospective Multicenter Double Blind Randomized Controlled Trial to Compare the Efficacy of the H7-Coil to H1-Coil Deep Transcranial Magnetic Stimulation (DTMS) in Subjects with Major Depression Disorder (MDD) Save

Date Added
February 28th, 2017
PRO Number
Pro00061794
Researcher
Mark George
Keywords
Depression
Summary

The purpose of this study is to compare the antidepressant efficacy of two different coils used to stimulate the brain during rTMS (repetitive TMS), including the evaluation of both the safety and effectiveness of the test article for the H-7 coil. This study compares the H7-coil (which is new and experimental, and not FDA approved at this time) to the H1-Coil (which is FDA approved to treat depression) deep brain rTMS in subjects with Major Depressive Disorder (MDD).

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843 876 5142
schmidm@musc.edu

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

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

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

Focal Electrically-Administered Seizure Therapy (FEAST): Studies at two enrolling sites to further test and refine the treatment Save

Date Added
May 5th, 2015
PRO Number
Pro00042678
Researcher
Mark George
Keywords
Depression
Summary

We have invented a new way of delivering current during electroconvulsive therapy (ECT), using a modified direct current that allows more precise delivery of the electricity. Two previous studies have now allowed us to refine and improve this method. Here we propose a two-site (MUSC, GRU) study where we test how well this new method (FEAST) does, compared to conventional state of the art. We are interested in changes in depression ratings, cognitive side effects, and the effects on brain imaging (resting BOLD fMRI).

Institution
MUSC
Recruitment Contact
Jkeonye Moss
843 876 5142
mosjk@musc.edu

A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (with the H-ADD Coil) intended as an aid to Smoking Cessation Save

Date Added
April 8th, 2014
PRO Number
Pro00033326
Researcher
Mark George
Keywords
Pulmonary, Smoking
Summary

This research is being conducted at the Medical University of South Carolina Institute of Psychiatry Brain Stimulation Lab by Dr. Mark George to see if deep repetitive transcranial magnetic stimulation (dTMS) is effective in assisting participants to quit smoking. TMS is a noninvasive medical procedure that uses magnetic fields to stimulate nerve cells in the brain to act as an aid to smoking cessation. The treatment period will involve 18 active/sham treatments to be given daily for 3 weeks then weekly treatments in week 4, 5, and 6. A follow up visit will be scheduled about 2 1/2 months after week 6. The entire study is four months in duration. Participants who may be recruited into the study would include the following: men and women 22-70 years of age, chronic; heavy smokers who have smoked for more than 1 year, with no period of abstinence greater than 3 months during the past year; subjects who are motivated to quit smoking; subjects who have negative answers on the TASS; and those who are able to sign an informed consent.

Institution
MUSC
Recruitment Contact
Jkeonye Moss
843-876-5141
mosjk@musc.edu

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