Clinical Research Directory

Central Sensitisation in Nociceptive and Neuropathic Pain

This study aims to investigate differences in central sensitization among patients with chronic nociceptive pain, neuropathic pain, and mixed pain conditions. Chronic pain is a complex and multidimensional phenomenon involving sensory, cognitive, emotional, and behavioral components, often sustained by mechanisms of central sensitization that contribute to pain persistence and treatment resistance. Using a multidimensional assessment approach, the study integrates self-report questionnaires, neuropsychological evaluation, psychological measures, treatment adherence assessment, and neurophysiological investigation through laser-evoked potentials (LEP). Participants will be evaluated at baseline and after 12 months to explore differences between pain types and longitudinal changes in central sensitization, cognitive functioning, emotional status, and engagement with treatment. The findings are expected to improve the understanding of neurobiological and psychosocial mechanisms underlying different chronic pain phenotypes and to support more personalized and effective pain management strategies.

Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.

FDG PET/MR Imaging of Peripheral Pain Generators

The purpose of this research is to determine if a PET/MRI scan using FDG can accurately identify the source of chronic pain. Identifying the source of pain may help doctors treat chronic pain more effectively. Approximately 128 participants will be enrolled and can expect to be on study for up to 12 months.

Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population

This observational study aims to compare two nociception monitoring methods. The Nociception Level (NOL) index and the Surgical Pleth Index (SPI) in the pediatric population during general anesthesia. While both monitors are designed to assess nociceptive responses through autonomic nervous system activity, they differ in methodology and parameters measured. The NOL index integrates multiple physiological signals using a self-learning algorithm, while SPI focuses on heart rate variability and plethysmographic amplitude. Although both have been studied individually in children, a direct comparison has not yet been conducted. This study will evaluate and compare each monitor's ability to detect and quantify nociceptive stimuli (surgical and tetanic) in children. The investigators hypothesize that the NOL monitor and SPI monitor will both be able to quantify surgical stimuli and tetanic stimuli with monitors response to surgical stimuli \> monitors response to tetanic stimuli. However, the investigators also hypothesize that the NOL index will do this superiorly, as it utilizes a self-learning algorithm and more parameters are incorporated in its algorithm

Guiding Opioid Administration by Nociception Level Index (NOL) in Patients With Regional Anesthesia

General anesthesia consists of a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high-potency opioids to achieve antinociception during surgery is combining general anesthesia with regional anesthesia. Modern general anesthesia aims to avoid an overdose of opioid analgesics and reduce side effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed. In current clinical practice, opioid dosage is usually determined by clinical judgment. However, different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the most recent commercially available nociception indices is the Nociception Level Index (NOL). Until today, there is conflicting evidence on whether guiding sufentanil administration by NOL monitoring, which is the intended use of the nociception index, affects postoperative pain level in the postanesthesia care unit (PACU), the amount of postoperatively administered opioids, and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate the clinical performance of intraoperative NOL monitoring and determine whether guiding sufentanil administration by NOL monitoring - compared to routine care - reduces either postoperative pain level in the PACU, postoperative opioid consumption in the PACU or postoperative opioid consumption in the first 24 hours after the operation in patients having trauma and orthopedic surgery with combined general and regional anesthesia.

Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

The goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are: * Does ULF neuromodulation reduce chronic low back pain? * What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation? Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will: * Be randomly assigned to either the study device or to conventional medical treatments * Undergo standard surgical procedures to place the study device if assigned to the device arm * Attend regular clinic visits over 24 months for checkups and data collection

Unveiling Physiological and Psychosocial Pain Components with an Artificial Intelligence Based Telemonitoring Tool

The pAIn-sense study aims to revolutionize the monitoring and treatment of chronic pain, a major health concern that significantly impacts psychological well-being and quality of life. Traditional approaches to pain management face challenges like unspecific drug use and high healthcare costs, and they often leave patients dissatisfied. PAIn-sense aims at comprehensively understanding pain from both physical and emotional perspectives. To accomplish this, the study will employ advanced Artificial Intelligence (AI) techniques and wearable sensing technology. The study aims to monitor patients continuously, during both day and night activities, to gather a multidimensional set of data on their physiological, psychosocial, and pain conditions.

PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin

The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain with Spinal or Peripheral Nerve Origin. Primary Objectives: A) To quantify the bio-distribution of \[18F\] FTC-146 uptake in subjects with Spinal or Peripheral Nerve Origin pain and compare it with healthy controls. B) To determine whether painful schwannomas can be differentiated from non-painful schwannomas based on imaging. Secondary Objectives: A) To assess the reproducibility of \[18F\]FTC-146 PET imaging within the same healthy volunteer subjects using Test-Retest analysis. B) To investigate whether post-treatment \[18F\]FTC-146 uptake differs from pre-treatment uptake and correlate the imaging with subject reported pain level after treatment

Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.

This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit.

Cervical/Thoracic Neuromodulation and Nociceptive Processing

Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS.