Intelligent Spine Interface Study - Closed to Enrollment; PI: Jared Fridley, MD

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 I - 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 (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.

AO Foundation MTRON Study – Closed to Enrollment; 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 – Open for Enrollment; 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.

BRT-DA01 cell therapy for Parkinson’s Disease - Open for Enrollment; PI Dr. Wael F. Asaad, MD, PhD

BRT-DA01-301 is a Phase 3, double-blind clinical trial testing bemdaneprocel, a cell therapy for Parkinson’s disease (PD), in about 102 participants. Participants are randomly assigned to receive either the therapy via brain injections or a sham surgery, with both groups blinded to their treatment. Those receiving the therapy follow a year-long immunosuppressive regimen, while the sham group receives matching placebos. All participants continue their regular PD medications, with changes monitored to avoid affecting results. The study includes an 18-month double-blind phase, after which eligible sham participants may receive the therapy in an open-label extension. Safety is closely monitored throughout, and those receiving bemdaneprocel will be followed for up to five years.

RESTORE: Deep Brain Stimulation of the Cerebellum to Enhance Motor Recovery after Stroke; Open for Enrollment;
PI Dr. Wael F. Asaad, MD, PhD

RESTORE is a trial testing the safety and efficacy of deep brain stimulation of the cerebellum to improve hand function after stroke. It is a double-blinded, randomized, sham-controlled trial with a partial crossover design lasting 18 months. Participants will first undergo a five-month testing phase where they receive either real treatment—rehabilitation therapy combined with deep brain stimulation—or a control treatment with rehab therapy and non-therapeutic sham stimulation. After this phase, those in the control group may switch to the real treatment. The final six months involve follow-up to gather additional safety and long-term effectiveness data. 

ADvance-II Study – Closed to Enrollment; 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.

GTM-105 (BRIDGES): Beginning Radiation Immediately with GammaTile at GBM Excision Versus Standard of Care; 
PI Dr. Clark Chen MD PHD

Randomized clinical study to assess if the use of FDA-approved GammaTile® Therapy during brain tumor surgery helps increase the survival rate of patients compared to the usual standard of care treatment. Before surgical resection of the tumor, the study randomizes patients (2:1) to either receive the placement of GammaTile® combined with standard external beam radiation treatment (EBRT) & oral temozolomide (TMZ) vs. the standard of care treatment – surgery to remove the tumor, followed by sessions of EBRT and oral TMZ. The FDA approves both external radiation and GammaTile to treat brain cancer, but what’s new in this study is comparing the usual treatment to the usual treatment plus GammaTile to see which works better for this type of brain tumor.

MSB-DR004: A Prospective, multicenter, randomized, double-blinded controlled study to evaluate efficacy and safety of a single injection of rexlemestrocel-L combined with hyaluronic acid (HA) in subjects with moderate to severe chronic low back pain - Open for Enrollment; PI Dr. Alexios Carayannopoulos, DO, MPH

This Phase 3 aims to test whether a single injection of rexlemestrocel-L (a type of stem cell) combined with 1% hyaluronic acid into a damaged lumbar disc can reduce pain in people with moderate to severe chronic low back pain. These participants have disc degeneration that hasn’t improved with treatments like physical therapy or pain medications. The study will measure pain relief at 12 months and possibly up to 24 months. It will also look at whether the treatment improves quality of life, physical function, and reduces or eliminates the need for pain medications—especially opioids—compared to those who don’t receive the treatment.

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 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.

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 Medical^TM 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.