Research and Clinical Trials

Our Mission Includes Research

Goodman Campbell physicians have a dedicated interest in clinical research related to neurologic conditions. Our physician specialists and research team actively pursue and are involved in a variety of clinical trials. From infants to adults, we are researching areas including the brain, spine, stroke and interventional pain management. Our research nurses and staff are experts in their areas of study and in the clinical trials we are conducting. Please explore our research options below and contact us at 317-396-1300 with any questions.

Current Clinical Trials

Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator (REALITY)
Investigator: Derron Wilson, MD
Sponsor: Abbott Medical Devices
Focus: Patients scheduled to receive an implantable Abbott neurostimulation system for chronic pain are eligible for consideration in this study. The goal of the study is to collect safety and effectiveness data on various populations implanted with the systems.
ClinicalTrials.gov Identifier: NCT03876054

Spinal Cord Stimulation Trial to Permanent Prediction (SCS T2P), closed to enrollment- follow up only
Investigator: Derron Wilson, MD
Sponsor: Abbott Medical Devices
Focus: This is a proof-of-concept feasibility study in which external, non-invasive body sensors, global-positioning-system (GPS) location, clinical assessments, and patient surveys will be used to collect data from chronic pain patients prior, during and after trialing a spinal cord stimulation (SCS) system, (including post-permanent Implant for patients who choose to receive a permanently-implanted SCS system). This data is anticipated to provide important information regarding assessment of efficacy of therapy and the personalized needs of each patient.

Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter Spinal Cord Stimulator Systems in the Treatment of Chronic Pain
Investigator: Derron Wilson, MD
Sponsor: Boston Scientific
Focus: A study to evaluate the effectiveness of the systems in the management of chronic low back and/or leg pain, including one-sided or both sides associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, low back pain and leg pain.
ClinicalTrials.gov Identifier: NCT04618471

SOFia Aspiration System as First Line Technique (SOFAST)
Investigators: Daniel Sahlein, MD; Krishna Amuluru, MD; Andrew DeNardo, MD; John Scott, MD
Sponsor: Microvention
Focus: This is an observational study involving patients undergoing thrombectomy following acute ischemic stroke in the anterior circulation. The goal of the study is to assess functional, imaging and safety outcomes of the SOFIA aspiration catheter.

Embolization of the Middle Meningeal Artery with ONYXTM Liquid Embolic System for Subacute and Chronic Subdural Hematoma (EMBOLISE)
Investigators: Daniel Sahlein, MD; Krishna Amuluru, MD; Andrew DeNardo, MD; John Scott, MD; Eric Horn, MD; Charles Kulwin, MD; Saad Khairi, MD; Albert Lee, MD; Shannon McCanna, MD; Troy Payner, MD; MD; Richard Rodgers, MD
Sponsor: Medtronic
Focus: The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH).
ClinicalTrials.gov Identifier: NCT04402632

Brain Oxygen Optimization in Severe Traumatic Brain Injury- Phase 3 (BOOST-3)
Investigators: Richard Rodgers, MD; Charles Kulwin, MD; Eric Horn PhD, MD
Sponsor: The National Institute of Neurological Disorders and Stroke (NINDS)
Focus: A randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. The results of this study will help doctors discover if one of these methods is more safe and effective.
ClinicalTrials.gov Identifier: NCT03754114

SELECT2: A Randomized Controlled Trial to Optimize Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke, closed to enrollment- follow up only
Investigators: Daniel Sahlein, MD; Krishna Amuluru, MD; Andrew DeNardo, MD; John Scott, MD
Sponsor: University Hospitals Cleveland Medical Center, Stryker Neurovascular
Focus: SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.
ClinicalTrials.gov Identifier: NCT03876457

SCS Research Study
Investigators: Todd Schmidt, MD
Sponsor: MedtronicNeuro
Focus: To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
ClinicalTrials.gov Identifier: NT03763708

Clinical Evaluation of the i-STAT TBI Test
Investigators: Richard Rodgers, MD; Charles Kulwin, MD
Sponsor: Abbott
Focus: The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a CT scan in patients presenting with suspected mild traumatic brain injury who are 18 years of age or older. The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
ClinicalTrials.gov Identifier: NCT04171960

Electrophysiological Analysis of Epileptogenic Tissue
Investigator: Jodi Smith, MD
Sponsor: The Neurosurgery Foundation at Goodman Campbell
Focus: Translational research study utilizing tissue from seizure surgeries to test medications that may in the future be potential treatments for epilepsy. Pediatric patients undergoing surgical resection for epilepsy may be eligible to participate by donating the tissue removed during their epilepsy surgery.

Hydrocephalus Clinical Research Network (HCRN) Registry
Investigator: Jodi Smith, MD
Sponsor: Unfunded
Focus: This is a multi-center research network seeking to gather information regarding pediatric hydrocephalus and treatments. Pediatric patients undergoing treatment for hydrocephalus may be included.

A Pivotal Study of the Premia Spine TOPS System
Investigators: Eric Potts, MD; John DePowell, MD; Eric Horn, MD; Saad Khairi, MD; Charles Kulwin, MD; Jean-Pierre Mobasser, MD; Shannon McCanna, MD; Richard B. Rodgers, MD
Sponsor: Premia Spine
Focus: The TOPS System was designed as an alternative to fusion and is a motion preserving posterior spine implant designed to provide dynamic stabilization to a single lumbar spine segment following decompression surgery. The purpose of the trial is to assess whether the TOPS system is more effective than transforaminal lumbar interbody fusion (TLIF) when utilized in a specific population of patients undergoing single level lumbar fusion.
ClinicalTrials.gov Identifier: NCT03012776

Prospective, Randomized, Controlled, Blinded Pivotal Study in Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using InfuseTM Bone Graft and The CapstoneTM Spinal System With Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine
Investigators: Saad Khairi, MD; Eric Potts, MD; Eric Horn, MD; Charles Kulwin, MD; Shannon McCanna, MD; Richard B. Rodgers, MD; John DePowell, MD
Sponsor: Medtronic Spinal and Biologics
Focus: This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 1017 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of InfuseTM in transforaminal lumbar interbody fusion (TLIF) procedures and to obtain indication expansion for InfuseTM use in one and two level TLIF procedures.
ClinicalTrials.gov Identifier: NCT04073563

Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT) closed to enrollment- follow up only
Investigator: Derron Wilson, MD
Sponsor: Abbott Medical Devices
Focus: The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with comprehensive medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.
ClinicalTrials.gov Identifier: NCT04779787

SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery (SOLIS) closed to enrollment- follow up only
Investigator: Derron Wilson, MD
Sponsor: Boston Scientific
Focus: To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
ClinicalTrials.gov Identifier: NCT04676022

Goodman Campbell Brain and Spine physicians publish research results from clinical trials and independent clinical investigations in peer-reviewed biomedical journals. Abstracts, full-text articles and videos can be accessed through the following online resources:

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