Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study

Date Added
October 7th, 2025
PRO Number
Pro00146983
Researcher
Mark George

List of Studies


Keywords
Depression, Nervous System
Summary

In this study, we are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp.

The study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. We will check skin comfort, mood, and overall tolerability after each session.

Institution
MUSC
Recruitment Contact
Clayton Olash
843-243-7305
olash@musc.edu

Accelerated, Left Prefrontal Transcranial Magnetic Stimulation for Functional Seizures; An Open-Label Exploration of Feasibility, Tolerability, and Preliminary Efficacy

Date Added
September 2nd, 2025
PRO Number
Pro00144502
Researcher
Mark George

List of Studies


Keywords
Mental Health, Psychiatry
Summary

As growing research suggests noninvasive brain stimulation techniques have the potential to adjunct current treatments or treat Seizure-Type Functional Neurologic Disorder (FND-seiz), also known as Psychogenic Non-Epileptic Seizures (PNES), we aim to evaluate whether a form of accelerated intermittent theta burst transcranial magnetic stimulation (a-iTBS-rTMS), is a practical and well-tolerated treatment for people with this disorder. Transcranial Magnetic Stimulation or TMS uses magnetic pulses to stimulate a part of the brain involved in mood and thinking, the left dorsolateral prefrontal cortex, which has established benefits in disorders known to coincide in patients with FND-seiz, such as depression.

As an open-label, early feasibility study, enrolled participants will receive 6 to 10 treatment sessions each day over 3 to 5 days, with the goal of completing 30 total sessions. This approach was selected because similar protocols have already been shown to be safe and effective in other conditions, and the shortened treatment schedule in comparison to other protocols may make participation easier for people living with FND-seiz. The main goal of the study is to see how many participants can safely and comfortably complete at least 20 of the 30 TMS sessions.

The researchers will also evaluate changes in seizure frequency, quality of life, mood, post-traumatic stress symptoms, physical health, social functioning, and overall satisfaction with treatment. These outcomes will be measured before treatment and again four weeks afterward. The researchers also aim to explore whether people with overlapping conditions, such as depression or PTSD, respond differently to the treatment. Finally, given the overlap between epilepsy and FND-seiz, not all TMS providers are comfortable treating patients with FND-seiz when TMS is indicated for other conditions, thus the researchers aim to outline a protocol to ensure safety and increase TMS access for FND-seiz patients.

Institution
MUSC
Recruitment Contact
Joseph Chasen
(843) 637-1358
chasenj@musc.edu

Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS

Date Added
March 14th, 2025
PRO Number
Pro00137237
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

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.

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

Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression

Date Added
December 3rd, 2024
PRO Number
Pro00139739
Researcher
Mark George

List of Studies


Keywords
Anxiety, Depression
Summary

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.

Institution
MUSC
Recruitment Contact
Alexandra Herron
843 876 9004
herronal@musc.edu

Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression

Date Added
December 3rd, 2024
PRO Number
Pro00139739
Researcher
Mark George

List of Studies


Keywords
Anxiety, Depression
Summary

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.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Alexandra Herron
843 876 9004
herronal@musc.edu

Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

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.

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

Developing a method of reducing the strength of transcranial focused ultrasound (tFUS) to personalize treatment.

Date Added
March 5th, 2024
PRO Number
Pro00132894
Researcher
Mark George

List of Studies


Keywords
Vision/ Eye
Summary

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.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843 876 5142
hollanbr@musc.edu

Synchronized cervical or transcranial auricular Vagus Nerve Stimulation (taVNS) with prefrontal repetitive transcranial magnetic stimulation (rTMS) for treatment resistant depression (TRD)

Date Added
January 3rd, 2023
PRO Number
Pro00125468
Researcher
Mark George

List of Studies


Keywords
Depression
Summary

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.

Institution
MUSC
Recruitment Contact
Noah Vieira
8437928292
collieli@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 Randomised Controlled Trial of Frontal and Temporal Electroconvulsive Therapy (ECT) for Severe Depression (The RAFT ECT 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 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.

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



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