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

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

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

Date Added
May 2nd, 2017
PRO Number
Pro00062581
Researcher
Mark George

List of Studies

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)

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

List of Studies

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

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



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