Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorAsian Institute of Gastroenterology, India
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with CP confirmed by CECT, MRCP, or EUS based on Cambridge or Rosemont criteria.
Age 18-60 years.
Both genders
Disqualifiers
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.
Trial population
Adult participants aged 18-60 years with diagnosed chronic pancreatitis and healthy controls
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Painful Chronic Pancreatitis4 interventions
Group B: Painless Chronic Pancreatitis4 interventions
Group C: Healthy Controls4 interventions
Trial outcomes
Primary outcomes
1
Role of Central Sensitization
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
Time frame
At the time of the single study visitSecondary outcomes
1
Brain Connectivity
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
Time frame
At the time of the single study visit.2
Brain Metabolites
Quantification of brain metabolites in key brain regions using magnetic resonance spectroscopy
Time frame
At the time of the single study visit.3
Quantification of Blood-Based Metabolites
Quantification of blood-based metabolites to identify potential biomarkers associated with pain phenotypes in patients with chronic pancreatitis.
Time frame
At the time of the single study visit.Sponsors and contacts
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Source ClinicalTrials.gov