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

13 juli 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

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Studieorter

    • Telangana
      • Hyderabad, Telangana, Indien, 500032

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Role of Central Sensitization
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Brain Connectivity
Tidsram: 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
Tidsram: 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
Tidsram: 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.

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Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

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Studera stora datum

Studiestart (Faktisk)

6 januari 2026

Primärt slutförande (Beräknad)

6 november 2026

Avslutad studie (Beräknad)

30 november 2026

Studieregistreringsdatum

Först inskickad

13 juli 2026

Först inskickad som uppfyllde QC-kriterierna

13 juli 2026

Första postat (Faktisk)

16 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juli 2026

Senast verifierad

1 juli 2026

Mer information

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