Research

For more information on any of these studies, email or call: BrainStimLab@musc.edu / (843) 792-8292.

TMS/VNS: Synchronized Cervical or Auricular VNS With Prefrontal rTMS for TreatmentResistant Depression (TRD)

The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate 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). The investigators think this combined method might treat depressive symptoms better than either alone. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. 

The RAFT ECT Study (RAFT-ECT):

The Randomized Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study

Severe depression is devastating for those affected and is often associated with a significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects.

A new form of ECT which utilizes a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal electrode placement has good efficacy and less cognitive side effects than the conventional electrode placement.

Participation will involve receiving randomized acute ECT (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomized acute ECT treatments, though the number of treatments (and hence the length of the randomized acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgment.

REVEAL: Research Evaluating Vagal Excitation and Anatomical Links

The REVEAL study is designed to investigate the effects of vagus nerve stimulation (VNS) on autonomic, cardiovascular, immune, and metabolic systems in individuals aged 18 and older with major depressive disorder. The study aims to assess acute and chronic VNS effects through noninvasive and minimally invasive methods, including physiological tests and blood draws. Interventions, involving experimental VNS parameters and autonomic reflex assessments, span a timeline of 3 to 12 months, depending on the participant's condition. This is not a treatment study but aims to deepen understanding of VNS modulation mechanisms and their dependency on stimulation parameters.

This is not a study to treat depression but to research how VNS affects the peripheral organs in people diagnosed with depression. This is an active study (no sham) and participants will be randomized to exploratory settings that may or may not help with depression. Study participation will last approximately 19 weeks in total. After the study, the VNS can be adjusted to treat depression. Participants will be required to travel to the University of Minnesota for 2 visits and can bring a companion. The study will pay for flights, hotels, and other expenses for these trips to Minnesota.

Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD):

Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD

There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this study the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.

TRANSCEND: Treatment Resistant Depression Subcallosal Cingulate network DBS

The aim of this 12-month study is 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 Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to antidepressant treatments.

In a double-blind fashion, half the subjects will receive active DBS therapy, while half will receive sham stimulation. After the 12-month endpoint, all subjects will be unblinded to their treatment group, and subjects in the control arm will receive active DBS therapy.

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

A research study to evaluate whether Vagus Nerve Stimulation (VNS) Therapy can help reduce depression symptoms in individuals with treatment-resistant depression.

Who Can Participate?

• Adults diagnosed with bipolar disorder
• Must have Medicare

What to Expect:

• Participants will receive a VNS device implant.
• Some will have the device activated immediately, while others will have it activated after 12 months.
• After the initial 12-month study period, all participants will continue in a long-term follow-up study.