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Chronic PancreatitisNEURO-CPNCT07707609

Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis

An observational study of Chronic Pancreatitis and Pain Management, run by Asian Institute of Gastroenterology, India at 1 site in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Pancreatitis, Pain Management
What is being tested?
Comprehensive Neuropsychological Assessment, Resting-State Functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS)
How many people
200 participants
Where
1 siteIndia
Study dates
6 Jan 2026to 30 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

India1 site, 1 recruiting
  • Asian Institute of Gastroenterology

    Hyderabad, Telangana, 500032

    Abdul Rasheed, Pharm.D, +91 9652104726, abdulrasheedmd1223@gmail.com

    Rupjyoti Talukdar, MD, +91 7032804231, rup_talukdar@yahoo.com

    Recruiting

Other trials in India

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Comprehensive Neuropsychological Assessment, Resting-State Functional MRI (fMRI), Magnetic Resonance Spectroscopy (MRS), Blood-Based Metabolite Profiling
Keywords
Central Sensitisation, Pain, Neuroimaging, fMRI, MRS, Chronic Pancreatitis
Medical subject headings
Pancreatitis, Chronic, Agnosia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive Neuropsychological AssessmentDiagnostic test

    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)Diagnostic test

    An advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.

  • Magnetic Resonance Spectroscopy (MRS)Diagnostic test

    A neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.

  • Blood-Based Metabolite ProfilingDiagnostic test

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

Study groups in NCT07707609
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: Comprehensive Neuropsychological Assessment; Diagnostic Test: Resting-State Functional MRI (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Diagnostic Test: Blood-Based Metabolite Profiling
Painless Chronic PancreatitisPatients diagnosed with chronic pancreatitis who do not experience abdominal pain, serving as a disease control group
Receives: Diagnostic Test: Comprehensive Neuropsychological Assessment; Diagnostic Test: Resting-State Functional MRI (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Diagnostic Test: Blood-Based Metabolite Profiling
Healthy ControlsAge- and sex-matched individuals without any pancreatic or systemic diseases, serving as a healthy control group
Receives: Diagnostic Test: Comprehensive Neuropsychological Assessment; Diagnostic Test: Resting-State Functional MRI (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Diagnostic Test: Blood-Based Metabolite Profiling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At the time of the single study visit

Secondary outcomes (3)
  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

    Measured: At the time of the single study visit.

  2. Brain Metabolites

    Quantification of brain metabolites in key brain regions using magnetic resonance spectroscopy

    Measured: 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.

    Measured: At the time of the single study visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start6 Jan 2026
  3. Primary completion6 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07707609
Sponsor's protocol ID
NACP1
Acronym
NEURO-CP
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dimcevski G, Sami SA, Funch-Jensen P, Le Pera D, Valeriani M, Arendt-Nielsen L, Drewes AM. Pain in chronic pancreatitis: the role of reorganization in the central nervous system. Gastroenterology. 2007 Apr;132(4):1546-56. doi: 10.1053/j.gastro.2007.01.037. Epub 2007 Jan 25.

    PubMed 17408654
  • Faghih M, Phillips AE, Kuhlmann L, Afghani E, Drewes AM, Yadav D, Singh VK, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Pancreatic QST Differentiates Chronic Pancreatitis Patients into Distinct Pain Phenotypes Independent of Psychiatric Comorbidities. Clin Gastroenterol Hepatol. 2022 Jan;20(1):153-161.e2. doi: 10.1016/j.cgh.2020.10.036. Epub 2020 Oct 22.

    PubMed 34108130
  • Sarkar S, Sarkar P, M R, Hazarika D, Prasanna A, Pandol SJ, Unnisa M, Jakkampudi A, Bedarkar AP, Dhagudu N, Reddy DN, Talukdar R. Pain, depression, and poor quality of life in chronic pancreatitis: Relationship with altered brain metabolites. Pancreatology. 2022 Sep;22(6):688-697. doi: 10.1016/j.pan.2022.06.007. Epub 2022 Jun 8.

    PubMed 35710761
  • Keller CE, Wilcox CM, Gudleski GD, Branham S, Lackner JM. Beyond Abdominal Pain: Pain Beliefs, Pain Affect, and Distress as Determinants of Quality of Life in Patients With Chronic Pancreatitis. J Clin Gastroenterol. 2018 Jul;52(6):563-568. doi: 10.1097/MCG.0000000000000922.

    PubMed 28858939
  • Phillips AE, Faghih M, Drewes AM, Singh VK, Yadav D, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Psychiatric Comorbidity in Patients With Chronic Pancreatitis Associates With Pain and Reduced Quality of Life. Am J Gastroenterol. 2020 Dec;115(12):2077-2085. doi: 10.14309/ajg.0000000000000782.

    PubMed 32740078
  • Talukdar R, Reddy DN. Pain in chronic pancreatitis: managing beyond the pancreatic duct. World J Gastroenterol. 2013 Oct 14;19(38):6319-28. doi: 10.3748/wjg.v19.i38.6319.

    PubMed 24151350

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pancreatitis and Pain Management, run by Asian Institute of Gastroenterology, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Role of Central Sensitization (time frame: At the time of the single study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07707609, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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