Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis (NEURO-CP)

13 juillet 2026 mis à jour par: Rupjyoti Talukdar, Asian Institute of Gastroenterology, India

EVALUATION OF THE RELATIONSHIP BETWEEN NEURAL SENSITISATION AND NEUROPSYCHOLOGICAL ALTERATIONS IN PATIENTS WITH PAINFUL CHRONIC PANCREATITIS

Chronic pancreatitis (CP) is a progressive inflammatory disease in which chronic abdominal pain affects up to 80% of patients and remains difficult to manage despite treatment of pancreatic pathology. Increasing evidence suggests that persistent pain is not solely driven by peripheral pancreatic abnormalities but also by central sensitization, involving maladaptive changes in central nervous system pain-processing pathways. While altered brain connectivity and neurochemical changes have been demonstrated in other chronic pain disorders, these mechanisms remain poorly characterized in CP.

This study aims to integrate clinical phenotyping with blood-based metabolite profiling and advanced neuroimaging, including resting-state functional MRI and magnetic resonance spectroscopy, to investigate the relationship between central sensitization, brain dysfunction, and neuropsychological alterations. The findings may identify objective neurobiological markers of pain and facilitate the development of mechanism-based, personalized treatment strategies for patients with chronic pancreatitis.

Aperçu de l'étude

Description détaillée

Chronic pancreatitis (CP) is a progressive inflammatory disorder affecting 50-100 per 100,000 adults globally, with 50-80% of patients experiencing debilitating abdominal pain. Despite advances in understanding pancreatic pathology, pain management remains inadequate, leading to high rates of opioid dependence (40%) and reduced quality of life. Traditional models attribute CP pain to peripheral mechanisms (e.g., ductal hypertension, inflammation), yet many patients report persistent pain even after surgical or endoscopic interventions. This paradox highlights the critical role for central mechanisms, including central sensitization.

Central sensitization refers to increased responsiveness of nociceptive neurons in the central nervous system (CNS) to normal or subthreshold afferent input. In CP, prolonged peripheral inflammation may induce long-lasting changes in the brain's pain processing pathways. Emerging literature in other chronic pain conditions (e.g., fibromyalgia, irritable bowel syndrome) supports the notion that central sensitization is associated with altered brain connectivity and neurochemical imbalances. However, few studies have explored this in CP, and none have integrated central sensitization with neuropsychological dysfunction, which frequently co-occurs in chronic pain states.

Understanding these CNS mechanisms is essential for redefining pain management in CP. By combining clinical phenotyping, advanced neuroimaging (resting-state fMRI and MR spectroscopy), our study aims to offer a comprehensive picture of how altered brain function contributes to the pain experience. Identifying neurobiological markers of pain will also support the development of mechanism-based therapies and allow better stratification of patients who may benefit from central neuromodulatory interventions.

This prospective observational study will enroll 200 participants (120 with painful CP, 30 with painless CP, and 50 healthy controls) over one year. Participants will undergo clinical assessments, pain detection questionnaires (Izbicki, painDetect), and evaluations for quality of life (EORTC QLQ-C30 + PAN28), mental state (HADS), and sleep quality (PSQI). The primary assessments include Pancreatic Quantitative Sensory Testing (P-QST) to evaluate sensitization, resting-state fMRI to assess brain connectivity, and MR Spectroscopy to evaluate brain metabolites. Blood samples will be collected from all participants to quantify blood-based metabolites for exploratory biomarker analysis to identify potential correlates with pain phenotypes in chronic pancreatitis.

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Telangana
      • Hyderabad, Telangana, Inde, 500032
        • Recrutement
        • Asian Institute of Gastroenterology
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult participants aged 18-60 years with diagnosed chronic pancreatitis and healthy controls

La description

Inclusion Criteria:

  • Diagnosed with CP confirmed by CECT, MRCP, or EUS based on Cambridge or Rosemont criteria.
  • Age 18-60 years.
  • Both genders

Exclusion Criteria:

  • Recent episode of acute pancreatitis or ongoing pain (VAS >5).
  • Pancreatic cancer and other significant comorbidities.
  • Recent use of antidepressants, anxiolytics, high-potency opioids, or neuromodulators.
  • Pregnancy and lactation.
  • Inability to give informed consent.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Painful Chronic Pancreatitis
Patients diagnosed with chronic pancreatitis (CP) confirmed by CECT, MRCP, or EUS (based on Cambridge or Rosemont criteria), who experience significant abdominal pain.
A comprehensive set of clinical and neurological tests to be performed on all participants. This includes validated mental state and sleep evaluations (HADS, PSQI), quality-of-life assessments (EORTC QLQ-C30 + PAN28),and quantitative sensory testing (P-QST)
An advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.
A neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.
Blood samples will be collected from all participants to quantify metabolomic signatures and to identify potential correlates with pain phenotypes in chronic pancreatitis.
Painless Chronic Pancreatitis
Patients diagnosed with chronic pancreatitis who do not experience abdominal pain, serving as a disease control group
A comprehensive set of clinical and neurological tests to be performed on all participants. This includes validated mental state and sleep evaluations (HADS, PSQI), quality-of-life assessments (EORTC QLQ-C30 + PAN28),and quantitative sensory testing (P-QST)
An advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.
A neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.
Blood samples will be collected from all participants to quantify metabolomic signatures and to identify potential correlates with pain phenotypes in chronic pancreatitis.
Healthy Controls
Age- and sex-matched individuals without any pancreatic or systemic diseases, serving as a healthy control group
A comprehensive set of clinical and neurological tests to be performed on all participants. This includes validated mental state and sleep evaluations (HADS, PSQI), quality-of-life assessments (EORTC QLQ-C30 + PAN28),and quantitative sensory testing (P-QST)
An advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.
A neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.
Blood samples will be collected from all participants to quantify metabolomic signatures and to identify potential correlates with pain phenotypes in chronic pancreatitis.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Role of Central Sensitization
Délai: At the time of the single study visit
To evaluate the role of central sensitization and its neuropsychological correlates on pain in patients with chronic pancreatitis (CP) compared to painless CP and healthy controls
At the time of the single study visit

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Brain Connectivity
Délai: At the time of the single study visit.
Quantitative assessment of resting-state functional connectivity within key pain-processing networks (default mode network, salience network, and sensorimotor network) in patients with chronic pancreatitis
At the time of the single study visit.
Brain Metabolites
Délai: At the time of the single study visit.
Quantification of brain metabolites in key brain regions using magnetic resonance spectroscopy
At the time of the single study visit.
Quantification of Blood-Based Metabolites
Délai: At the time of the single study visit.
Quantification of blood-based metabolites to identify potential biomarkers associated with pain phenotypes in patients with chronic pancreatitis.
At the time of the single study visit.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 janvier 2026

Achèvement primaire (Estimé)

6 novembre 2026

Achèvement de l'étude (Estimé)

30 novembre 2026

Dates d'inscription aux études

Première soumission

13 juillet 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

16 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner