An observational study in Spinal Cord Injury, sponsored by Monaldi Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Monaldi Hospital · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 33 studies in Spinal Cord Injuries with a site in Italy — 9 open to participants now, 12 under way, none of them phase 3. Spinal Cord Injuries · Italy.
Among the 33 studies in Spinal Cord Injuries with a site in Italy, this one is one of 3 that started in 2025, is one of 6 observational ones, reaches primary completion later than 2 of the 11 other live ones, and was the 25th registered.
2,026 studies on the registry are indexed under Spinal Cord Injuries; 538 are open to participants now.
Browse Spinal Cord Injuries studies →9 of the 33 studies in Spinal Cord Injuries with a site in Italy are open now. Recruiting first, the newest first:
IRCCS Eugenio Medea · Sites in Italy
Ages 12–50 · Healthy volunteers
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18–80
IRCCS San Camillo, Venezia, Italy · Sites in Italy
Ages 18+
Ernesto Losavio · Sites in Italy
Ages 18+
Catholic University, Italy · Sites in Italy
Ages 18–85
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 120 is above the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.
Median enrollment 30 across the 27 interventional studies, 97 across the 6 observational. Of the 18 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 33 have an industry lead sponsor. The 10 most frequent:
Monaldi Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Monaldi Hospital has 1 study filed under Spinal Cord Injuries — fewer than ten, so there is no comparison to draw.
7 of the studies in Spinal Cord Injuries with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT07541612Monaldi HospitalNIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY | 2026-12-31 |
| NCT07621900I.R.C.C.S. Fondazione Santa LuciaEffects of Lokomat Training on Dynamic Postural Stability in Incomplete Spinal Cord Injury | 2027-05-01 |
| NCT07794072Catholic University, ItalyDigital Patient Engagement in Technology-Supported Neurorehabilitation | 2027-07-01 |
| NCT07865260Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero AvanzatoPhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults | 2027-09 |
Add all 7 to your calendar (.ics) → With an account.
Among the 33 studies in Spinal Cord Injuries with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective observational study aims to evaluate the feasibility and clinical utility of near-infrared spectroscopy (NIRS) monitoring applied to paraspinal muscles as a surrogate marker of spinal cord perfusion in patients undergoing major noncardiac surgery.
Spinal cord ischemia represents a rare but devastating complication, often difficult to detect in real time. NIRS provides a non-invasive, continuous monitoring of regional tissue oxygen saturation (rSO₂), potentially reflecting microcirculatory changes in paraspinal tissues and indirectly spinal cord perfusion.
The study will enroll adult patients undergoing major surgery requiring advanced hemodynamic monitoring. NIRS sensors will be placed over paraspinal regions, and rSO₂ values will be continuously recorded throughout the perioperative period. Hemodynamic parameters, including arterial pressure, cardiac output, and other relevant clinical variables, will be simultaneously collected.
The primary objective is to assess changes in paraspinal rSO₂ during perioperative management and their relationship with systemic hemodynamic variables. Secondary objectives include the evaluation of the association between rSO₂ variations and postoperative neurological outcomes, as well as the feasibility and reliability of this monitoring technique in routine clinical practice.
This study may provide preliminary evidence supporting the use of NIRS as a bedside, non-invasive tool for early detection of impaired spinal cord perfusion and for guiding hemodynamic optimization strategies.
pinal cord ischemia is a rare but severe complication associated with major surgical procedures, particularly in patients undergoing complex hemodynamic management. Early detection of impaired spinal cord perfusion remains challenging due to the lack of reliable, continuous, and non-invasive monitoring tools. Current monitoring strategies are indirect and often fail to provide timely information on regional perfusion changes.
Near-infrared spectroscopy (NIRS) is a non-invasive technique that measures regional tissue oxygen saturation (rSO₂) by analyzing the absorption of infrared light by oxygenated and deoxygenated hemoglobin. When applied to paraspinal muscles, NIRS may reflect local microcirculatory changes and potentially serve as a surrogate marker of spinal cord perfusion.
This is a single-center, prospective observational study designed to investigate the feasibility and clinical applicability of paraspinal NIRS monitoring in adult patients undergoing major noncardiac surgery requiring advanced hemodynamic monitoring. Patients will be monitored intraoperatively and during the early postoperative period using NIRS sensors placed bilaterally over the paraspinal regions.
Continuous rSO₂ measurements will be collected and integrated with routinely monitored hemodynamic variables, including arterial blood pressure, heart rate, and, when available, advanced parameters such as cardiac output and dynamic indices of fluid responsiveness. Data will be recorded at predefined time points and during relevant clinical events, such as induction of anesthesia, surgical phases, hemodynamic instability, and postoperative recovery.
The study aims to explore the physiological relationship between paraspinal rSO₂ and systemic hemodynamic changes, as well as to assess the feasibility, signal stability, and reproducibility of NIRS measurements in the perioperative setting. Particular attention will be given to identifying patterns of rSO₂ variation associated with hemodynamic fluctuations.
Data will be prospectively collected using standardized case report forms (CRFs). Data quality will be ensured through predefined data entry procedures, consistency checks, and periodic review of collected variables. All data will be anonymized prior to analysis.
A descriptive statistical approach will be used to summarize baseline characteristics and perioperative variables. Exploratory analyses will be conducted to evaluate the association between rSO₂ trends and hemodynamic parameters. Where appropriate, correlation analyses and regression models may be applied to investigate potential predictors of rSO₂ variation.
Given the exploratory nature of the study, no formal sample size calculation is required; however, enrollment is planned to ensure an adequate representation of the target population and to allow meaningful exploratory analysis.
This study is expected to provide preliminary evidence on the role of paraspinal NIRS monitoring as a non-invasive bedside tool for assessing tissue oxygenation and potentially guiding perioperative hemodynamic management strategies.
Adult patients undergoing elective thoracic and thoracoabdominal aortic repair procedures, including open, endovascular (TEVAR/FEVAR), and hybrid interventions, at Monaldi Hospital, A.O.R.N. Ospedali dei Colli, Naples, Italy. Participants will be recruited consecutively from the vascular and cardiovascular surgical units where intraoperative spinal cord monitoring is routinely performed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients aged 18 years or older Patients scheduled for elective thoracic or thoracoabdominal aortic repair, including open, endovascular (TEVAR/FEVAR), or hybrid procedures Patients undergoing intraoperative paraspinal near-infrared spectroscopy (NIRS) monitoring Written obtained before enrollment
Exclusion Criteria:
Age under 18 years Emergency surgical procedures Pregnancy Pre-existing paraplegia or severe neurological impairment Skin lesions or conditions preventing correct placement of NIRS sensors Refusal or inability to provide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients at high risk of spinal cord ischemia undergoing aortic surgery, managed with paraspinal near-infrared spectroscopy (NIRS) monitoring combined with cerebrospinal fluid (CSF) drainage according to the study protocol.
Diagnostic Test: Near-Infrared Spectroscopy (NIRS) · Procedure: Cerebrospinal fluid drainage via lumbar catheter (L3-L4) to maintain cerebrospinal fluid pressure below target levels and optimize spinal cord perfusion pressure during aortic surgery.
Patients at lower risk of spinal cord ischemia undergoing aortic surgery, managed with paraspinal near-infrared spectroscopy (NIRS) monitoring without cerebrospinal fluid drainage according to the study protocol.
Diagnostic Test: Near-Infrared Spectroscopy (NIRS)
Paraspinal sensors are applied bilaterally at thoracic-lumbar levels (approximately T8-L2) to continuously monitor regional oxygen saturation (rSO2). Data are recorded intraoperatively and during the early postoperative period (up to 72 hours), allowing detection of changes potentially associated with spinal cord hypoperfusion.
Also known as: NIRS MONITORING, REGIONAL OXIMETRY, rSO2 monitoring, Near-Infrared Spectroscopy
A lumbar cerebrospinal fluid drainage catheter is inserted (typically at L3-L4) and managed to maintain cerebrospinal fluid pressure below 10 mmHg, with the aim of optimizing spinal cord perfusion pressure (SCPP ≥75 mmHg) during and after aortic surgery.
Also known as: CSF DRAINAGE, LUMBAR DRANAIGE, CEREBROSPINAL FLUID DRANAIGE, SPINAL DRANAIGE
Intraoperative detection of spinal cord ischemia by paraspinal NIRS
Incidence of intraoperative spinal cord ischemia identified by significant reduction in paraspinal regional oxygen saturation measured with near-infrared spectroscopy during thoracoabdominal aortic surgery.
Time frame: From anesthesia induction until completion of surgery
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 124 non-industry observational studies under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 74. This study's planned 16 months is below that.
Counting every sponsor, half of 135 studies reached it within 39 months; a quarter within 16 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Monaldi Hospital