Clinical Research Directory

Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

The investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve the strength, function, and sensation of paralyzed muscles after a spinal cord injury.

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group. The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

Effect of an Interdisciplinary Spine Rehabilitation Program

The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.

Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.

Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery

The purpose of the study is to assess, through systematic screening, the prevalence of diabetes or prediabetes in patients who are candidates for lumbar spine surgery.

Wearable Flexible Sensors for Spinal Motion Monitoring

With the deepening of societal aging, degenerative spinal diseases have become increasingly prevalent in China and are one of the leading causes of disability among middle-aged and elderly populations. Current musculoskeletal assessment methods primarily focus on imaging rather than functional evaluation, and emphasize static over dynamic analysis, failing to capture the daily functional state of the musculoskeletal system. This limitation hinders a deeper understanding of functional patterns and their role in the progression of degenerative spinal diseases. Therefore, there is an urgent need to develop precise and dynamic functional assessment methods that overcome the constraints of time and space in measurement. This project adopts a dynamic perspective of the musculoskeletal system, developing a wearable monitoring approach based on flexible sensors to assess limb and spinal motion. The method will be validated against traditional imaging techniques such as X-ray and ultrasound, laying the foundation for investigating the pathogenesis of degenerative spinal diseases. This research aligns with China's strategic initiatives and practical needs in addressing the challenges of an aging population.

Progressive Advancements in Neurosurgery, Data and Analysis Database

Neurosurgical diseases encompass a highly heterogeneous group of conditions, including oncological, malformative, traumatic, spinal, vascular, infectious diseases, and cerebrospinal fluid dynamics disorders. Several systematic reviews on the level of evidence in neurosurgical diseases have documented the low percentage of high-quality scientific evidence in this field of medicine. Clinical practice is strongly influenced by individual physician preferences, leading to significant heterogeneity among different centers both in Italy and internationally. This overall picture highlights the need for tools that can accurately characterize the numerous diagnostic variables influencing therapeutic outcomes in patients with neurosurgical diseases. Primary Objective To establish a prospective data collection of adult patients with neurosurgical diseases, providing real-life data on the current management of patients at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome and the participating centers. Secondary Objectives To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials. To conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available. To identify potential predictors of poor outcomes or treatment response. To assess the clinical history and treatment response of patients, including for internal audit purposes (e.g., supporting Morbidity \& Mortality conferences). To provide support for the development and monitoring of quality indicators related to patient care.

Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)

This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.

Gait Spine Functional Evaluation Protocol

The goal of this clinical trial is to develop and validate of a new protocol for multifactorial functional assessment of the kinematics of spinal and total body movements during walking by means of the optoelectronic motion analysis system in healthy and scoliosis subjects. The main questions it aims to answer are: * Is feasibility developing a protocol to assess the spine kinematic during walking? * Is the intra and inter operator reliability of the developed protocol acceptable? * Is the usability of the developed protocol acceptable? During data acquisition a trained therapist placed reflective markers on the skin of the participants in the selected body landmarks. The participants will be asked to perform five trial of walking barefoot on a 6 meters distance at a self-selected normal-pace speed, for each session.

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.

The Effect of Intrawound Vancomycin Powder in Spine Surgery

Problem: Postoperative wound infection following various spinal surgeries is a serious complication. The incidence of post-surgical wounds in spine surgery is high, and various researchers have reported different infection rates. In addition, increased healthcare costs, prolonged lengths of stay in hospital, and reduced quality of life as a result of surgical site infections (SSI) are also major concerns. Several methods for avoiding SSI, such as betadine irrigation, vacuum-assisted closure, and intra-wound vancomycin powder, have been used to reduce the rate of wound infection in spine surgery. Use of local vancomycin has been popular because of its protective effects and lower cost. According to some reports, prophylactic administration of intra-wound vancomycin powder before wound closure is an effective method for decreasing postoperative wound infection rates; however, other studies have revealed a non-significant effect of intra-wound vancomycin use for decreasing the postsurgical wound infection rate. Solution: Therefore, the investigators will prospectively randomize all various types of spinal surgeries to patients who will receive intrawound vancomycin powder and control group who will not receive the powder and to see it's effect in reducing the post-surgical infection.

MRI Analysis and Degenerative Spine

Analysis of MRI advanced techniques in degenerative spinal disease. The main questions it aims to answer are: * Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease * What are the image biomarkers affected by disease * How they evolve with disease progression and treatment