Enrolling and Completed Studies

The Spine and Nerve Center of the Virginias stands at the forefront of global clinical research, dedicated to advancing minimally invasive spine and nerve treatments and securing FDA approvals for innovative therapies. Our center has played a pivotal role in renowned studies, including ACCURATE, SUNBURST, EVOKE, DISTINCT, and many others. These studies have contributed to regulatory approvals for groundbreaking advancements, such as dorsal root ganglion stimulation, novel waveforms for chronic pain management, closed-loop devices integrating artificial intelligence into spinal cord stimulation, and expanded FDA indications, notably non-surgical low back pain for implantable therapies.

Furthermore, our commitment extends to pioneering developments in minimally invasive spine surgery, aimed at enhancing patient outcomes and safety. These advancements have led to shorter recovery times and a reduced risk of complications. As a result of our dedicated research and product development efforts, our center frequently leads the world in introducing cutting-edge treatment options to patients.

If you are interested in participating in one of our ongoing studies, please contact our Research Coordinator:

Email: Amy.young@thomashealth.org

DISTINCT will evaluate the efficacy of BurstDR spinal cord stimulation to relieve pain and improve physical function in people with chronic low back pain who have not had back surgery and for whom other treatments, such as medication, physical therapy and injections, have failed.

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain).

The Vertiflex PRESSS study is designed to gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.

The Evoke® Closed-Loop System is the first and only SCS system designed to measure the spinal cord’s response to stimulation and automatically adjust stimulation in real-time to optimize pain relief. The primary goal of the newly initiated ECAP Study is to further evaluate the relationship between neurophysiological measures and clinical outcomes of the Evoke® Closed-Loop System.

Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up.

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott’s neurostimulation systems.

The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management. The treatment arm utilized an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms.

The ACCURATE study is the largest randomized, controlled neuromodulation trial conducted in CRPS and peripheral causalgia patients to provide evidence of safety and efficacy for market approval in the United States.

The Evoke® Closed-Loop System is the first and only SCS system designed to measure the spinal cord’s response to stimulation and automatically adjust stimulation in real-time to optimize pain relief. The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.

The SCOPE Study is designed to compile real-world outcomes of the Superion® IDS in routine clinical practice, when used according to the applicable Directions for Use

ROSTRA is an international, prospective, non-randomized, single-arm, multi-center, and post-market study to collect real-world safety and effectiveness data on Abbott’s IonicRF™Generator and compatible RFA accessories. This post-market study is intended to satisfy EU MDR requirements.