Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis
- Sponsor
- Asian Institute of Gastroenterology, India
- Study ID
- NCT07707609
- Status
- Recruiting
Conditions
- Chronic Pancreatitis
- Pain Management
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Comprehensive Neuropsychological Assessment — DIAGNOSTIC_TESTA 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) — DIAGNOSTIC_TESTAn advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.
- Magnetic Resonance Spectroscopy (MRS) — DIAGNOSTIC_TESTA neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.
- Blood-Based Metabolite Profiling — DIAGNOSTIC_TESTBlood samples will be collected from all participants to quantify metabolomic signatures and to identify potential correlates with pain phenotypes in chronic pancreatitis.
Study Details
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.
Key Dates
- First listed
- Jul 16, 2026
- Start date
- Jan 6, 2026
- Status verified
- Jul 2026
- Primary completion
- Nov 6, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: Painful Chronic PancreatitisPatients diagnosed with chronic pancreatitis (CP) confirmed by CECT, MRCP, or EUS (based on Cambridge or Rosemont criteria), who experience significant abdominal pain.
- Arm: Painless Chronic PancreatitisPatients diagnosed with chronic pancreatitis who do not experience abdominal pain, serving as a disease control group
- Arm: Healthy ControlsAge- and sex-matched individuals without any pancreatic or systemic diseases, serving as a healthy control group
Primary Outcome Measure
Role of Central Sensitization [ Time Frame: At the time of the single study visit ]
Related Studies
- Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic DisordersRecruiting · Mayo Clinic · Phoenix, Arizona
- Pancreas Registry and High Risk RegistryRecruiting · Icahn School of Medicine at Mount Sinai · New York, New York
- Analysis of Graft Function Following Autologous Islet TransplantationRecruiting · Baylor Research Institute · Dallas, Texas
- QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory TestingRecruiting · Anna Evans Phillips · Baltimore, Maryland