This study is designed as a prospective, multi-centered, double-blind, randomized, delayed-stimulation/ sham-stimulation controlled 12-month study to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.
In this pilot study we will assemble a portable TMS(transcranial magnetic stimulation) unit, in a van, and then test out delivering TMS in Medical University of South Carolina (MUSC)-affiliated facilities in South Carolina, all within 90 minutes of driving from Charleston, SC. This work will hopefully open up access to TMS for millions of patients with treatment-resistant depression who cannot be treated in the current model.
We will recruit up to 30 treatment-resistant depression patients who live near one of the MUSC-affiliated clinics. We will treat these patients, open-label, with FDA-approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). We will measure TMS effectiveness using standard depression rating scales.
In this pilot study we will assemble a portable TMS(transcranial magnetic stimulation) unit, in a van, and then test out delivering TMS in Medical University of South Carolina (MUSC)-affiliated facilities in South Carolina, all within 90 minutes of driving from Charleston, SC. This work will hopefully open up access to TMS for millions of patients with treatment-resistant depression who cannot be treated in the current model.
We will recruit up to 30 treatment-resistant depression patients who live near one of the MUSC-affiliated clinics. We will treat these patients, open-label, with FDA-approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). We will measure TMS effectiveness using standard depression rating scales.
This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.
Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. We do not yet have an easily observable way to know whether we are in the right brain location with the correct dose for that person. We wonder if we can produce a transient change in someone's visual field, called a scotoma, and whether we can use that to determine the minimum tFUS dose for that person.
Currently rTMS for treating depression is delivered without knowing whether the TMS pulses are synchronized with the patient's brain rhythms. We will study healthy and depressed adults with TMS inside of the MRI scanner or outside of the MRI scanner using optics, and test whether it matters precisely timing the TMS pulses with EEG.
The purpose of the research is to test out a combined treatment for depression where we stimulate a nerve in the ear while at the same time stimulating the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For patients who already have a cervical VNS device, we will not change their treatment and will use this in place of the taVNS. We think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, patients will have a screening session and then will have 6 treatment days total where they will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment they start with will be randomized, and they will have 2 treatment days of each combination.
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 Frontal (Ultrabrief Right Unilateral) ECT. If enrolled in this this study, participants will be randomly assigned (like flipping a coin) to receiving Frontal ECT or the current standard form of ECT called Temporal (Ultrabrief Right Unilateral) ECT.
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.