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Clinical Trials in India / NCT07707609
Recruiting Observational

Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis

NCT07707609 · tracked via the Priya Life Science India tracker
Sponsor
Asian Institute of Gastroenterology, India
Phase
Observational
Started
2026-01-06
Last updated
2026-07-16

Condition(s) studied

Chronic PancreatitisPain Management

Investigational drug(s) / intervention(s)

Comprehensive Neuropsychological AssessmentResting-State Functional MRI (fMRI)Magnetic Resonance Spectroscopy (MRS)Blood-Based Metabolite Profiling

Comprehensive Neuropsychological Assessment: 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)

Resting-State Functional MRI (fMRI): An advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.

Magnetic Resonance Spectroscopy (MRS): A neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.

Blood-Based Metabolite Profiling: Blood samples will be collected from all participants to quantify metabolomic signatures and to identify potential correlates with pain phenotypes in chronic pancreatitis.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asian Institute of Gastroenterology Hyderabad Telangana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07707609 on ClinicalTrials.gov ↗ ← All trials in India