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

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases
Investigators: Charles Kulwin MD, Kushal Shah MD
Sponsor: NRG Oncology
Focus: This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. Identifier: NCT05438212

Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator (REALITY), closed to enrollment- follow up only
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. Identifier: NCT03876054

A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs
Investigators: Derron Wilson MD, Todd Schmidt MD
Sponsor: Saluda Medical Pty Ltd
Focus: Patients planning to have a temporary trail with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs. The goal of the study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e. neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs. Identifier: NCT06229470

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, closed to enrollment- follow up only
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. Identifier: NCT04618471

REal-World Analyses of Stroke – Thrombus Occlusion Retrieval (RESTORE)
Investigators: Daniel Sahlein MD, Krishna Amuluru MD, Andrew DeNardo MD
Sponsor: Microvention
Focus: This is a prospective, multi-center, single arm, observational Real World Evidence (RWE) post-market study with two cohorts. The study objective is to collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician. Identifier: NCT04451525

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, Charles Kulwin MD, Saad Khairi MD, Albert Lee MD, Shannon McCanna MD, Troy Payner 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). Identifier: NCT04402632

Brain Oxygen Optimization in Severe Traumatic Brain Injury- Phase 3 (BOOST-3)
Investigators: Richard Rodgers MD, Charles Kulwin MD, Vincent Alentado 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. 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
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. 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. Identifier: NT03763708

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, closed to enrollment- follow up only
Investigators: Eric Potts MD, John DePowell 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. 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, 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. Identifier: NCT04073563

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. 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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