Research

Research Clinical Trials

We are proud to host an array of clinical trials for our patients so that they can take advantage of some of the newest treatment options for their conditions, and test some of the most recent technological innovations in neurosurgery. Our clinical trial efforts are assisted by collaborations with the Rhode Island Hospital (Level 1 Trauma Center) & Hasbro Children’s Hospital Emergency Departments, the Lifespan Cancer Center, and the Norman Prince Spine Institute.

 

Below are some of our ongoing clinical trials:

Spinal Cord Injury Research Studies

Intelligent Spine Interface Study: *As of 1/1/2021, enrollment for this study is on hold until COVID restrictions are lifted.

Clinical research trial to understand how information is transmitted and processed in the spinal cord after spinal cord injury. Electrodes are placed in the spine above and below the site of injury, and both stimulation and recording performed. The gathered information is processed via a state-of-the-art artificial neural network-based interpreter. The goal is to create a bidirectional spinal cord interface to bridge the spinal cord injury gap. The proposed technology is agnostic to the level of the spinal lesion and has many sites (electrodes) to interact with the nervous system, which makes the therapeutic potential far greater than current technologies. Initial stages of the study are proof of concept, with the hope that a working ISI device will be developed in later stages.

InVivo INSPIRE 2.0 Trial – ENROLLING Subjects; PI Dr. Adetokunbo Oyelese MD PhD

Multicenter study of the probable benefit of the Neuro-Spinal Scaffold™ by InVivo Therapeutics in terms of safety and neurologic recovery in patients with complete thoracic spinal cord injury (AIS A). Patients are enrolled who present to the Rhode Island Hospital or Hasbro Children’s Hospital with acute spinal cord injury and meet all study-specific inclusion criteria, and are randomized to possibly receive an implantable, biodegradable device designed to encourage axonal regrowth into the damaged region of the spinal cord.

Traumatic Brain Injury Research Studies

Vivonics IPASS Study – ENROLLING Subjects; PI Dr. Wael Asaad MD PhD, Co-I Dr. Ali Mahta MD

Multicenter study of the IPASS system for non-invasive monitoring of intracranial pressure, which can increase dangerously in patients who have experienced a traumatic brain injury or hydrocephalus, for example. This study is carried out in the neurocritical care unit (NCCU) in eligible subjects, and is funded by Vivonics Inc and the United States Department of Defense.

Biogen Glibenclamide Study – ENROLLING; PI Dr. Wael Asaad MD PhD

Multicenter study of glibenclamide, a pharmaceutical agent by Biogen for reducing secondary brain injury and functional outcome following traumatic brain contusion. Patients who are eligible will be enrolled from the Rhode Island Hospital Emergency Department and receive a 72-hour infusion of this novel treatment also being studied in other acute brain conditions like ischemic stroke.

Disorders and Diseases of the Spine Research Studies

AO Foundation MTRON Study – ENROLLING Subjects; PI Dr. Ziya Gokaslan MD

Registry study enrolling patients undergoing neurosurgical treatment for metastatic cancer to the spine of any kind. Sponsored by the AO Spine Foundation, an international consortium of physicians who treat tumors and cancers of the spine, this registry will track long-term patient outcomes and potential benefits of surgical intervention by following enrolled subjects from pre-operative enrollment through disease resolution.

AO Foundation PTRON Study – ENROLLING Subjects; PI Dr. Ziya Gokaslan MD

Registry study enrolling patients undergoing neurosurgical treatment for primary tumors of the spine and sacrum. Sponsored by the AO Spine Foundation, an international consortium of physicians who treat tumors and cancers of the spine, this registry will track long-term patient outcomes and potential benefits of surgical intervention by following enrolled subjects from pre-operative enrollment through disease resolution.

Seikagaku Condoliase Study – Pending, Upcoming; PI Dr. Albert Telfeian MD PhD

Multicenter study by the Seikagaku corporation seeking to test the therapeutic benefit of condoliase, a pharmaceutical agent already shown to be safe and efficacious and developed to treat lumbar intervertebral disc herniation. Eligible subjects with this condition who meet eligibility criteria will be enrolled to receive a single injection treatment of this compound into the center of the herniated disc.

Functional Neurosurgery Research Studies

ADvance-II Study – ENROLLING Subjects; Site PI Dr. Wael Asaad, MD, PhD

ADvance-II is a multi-center clinical research trial investigating the efficacy of deep brain stimulation (DBS) for patients with mild Alzheimer’s disease. The study is sponsored by Functional Neuromodulation. DBS involves a brain implant which is being studied as a possible way to improve function in patients with Alzheimer’s disease. While the use of DBS for Alzheimer’s disease is new, DBS is FDA-approved as an effective treatment for other neurodegenerative diseases, such as Parkinson’s. The device is implanted just under the skin on the chest, and small leads are placed in the memory center of the brain to deliver electrical impulses to activate part of the brain that is affected by Alzheimer’s disease. We are looking to determine if this device will improve long-term function in patients with mild Alzheimer’s who are at least 65 years of age.

Neuropathic Pain & Neural Circuits Research Studies

Nevro RENEW Study – ENROLLING Subjects; PI Dr. Alexios Carayannopoulos, DO, MPH

Multi-center study investigating the effectiveness of HF10 therapy (High frequency spinal cord stimulation) for the treatment of trunk and/or limb pain in patients who have previously failed traditional spinal cord stimulation treatment.  This therapy is delivered by the Senza System and uses a higher frequency of electric stimulation compared to traditional spinal cord stimulators.

Vista Collar Study – ENROLLING Subjects; PI Dr. Alexios Carayannopoulos, DO, MPH

Single-center, randomized, controlled trial investigating the effectiveness of the Vista Collar to provide relief of neck and radicular pain caused by mechanical problems in the neck.  The Vista Collar is a cervical collar that uses an inflatable air bladder to provide controllable pressure to the mid cervical region of neck.

Closed to Enrollment

Abbott TARGET Study – Closed to Enrollment; PI Dr. Alexios Carayannopoulos, DO, MPH

Multi- center study investigating the safety and efficacy of the FDA approved DRG (Dorsal root ganglion) Neurostimulation System for the treatment of chronic lower limb pain due to CRPS (Complex Regional Pain Syndrome) types I and II.

InVivo INSPIRE Trial: Closed to Enrollment. PI Dr. Adetokunbo Oyelese MD, PhD

Multicenter study of the probable benefit of the Neuro-Spinal Scaffold™ by InVivo Therapeutics in terms of safety and neurologic recovery in patients with complete thoracic spinal cord injury (AISA). Patients are enrolled who present to the Rhode Island Hospital or Hasbro Children’s Hospital with acute spinal cord injury and meet all study-specific inclusion criteria, and receive an implantable, biodegradable device designed to encourage axonal regrowth into the damaged region of the spinal cord.

Vertex Pharmaceuticals SPRING Trial – Closed to enrollment; PI Dr. Adetokunbo Oyelese MD PhD

Multicenter study of efficacy and safety of VX-210 by Vertex Pharmaceuticals in patients with acute traumatic spinal cord injury to the cervical spine (AIS A or B). Patients are enrolled who present to the Rhode Island Hospital or Hasbro Children’s Hospital with acute spinal cord injury and meet all study-specific inclusion criteria, and are randomized to possibly receive an intraoperative pharmaceutical product applied during surgical decompression that may possibly improve neurological recovery after injury.

Mainstay Reactiv8 Trial – Closed to enrollment; PI Dr. Alexios Carayannopoulos, DO, MPH

Multi-center study evaluating the safety and effectiveness of an implantable electrical stimulation system called Reactiv8, to provide relief of chronic low back pain. Reactiv8 is a type of spinal stimulation system that causes muscle contraction in the lower back.

Abbott DELIVERY Trial – Closed to enrollment; PI Dr. Alexios Carayannopoulos, DO, MPH

Multi-center study comparing an anatomical versus a traditional lead placement for the BurstDR spinal cord stimulator, with the use of the St. Jude MedicalTM Invisible Trial system.  BurstDR is a stimulator used to treat trunk and limb pain. It differs from other spinal cord stimulators in that it does not cause a pins and needles or numbing sensations.