- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07707609
Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis (NEURO-CP)
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi helyek
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Telangana
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Hyderabad, Telangana, India, 500032
- Toborzás
- Asian Institute of Gastroenterology
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Kapcsolatba lépni:
- Abdul Rasheed, Pharm.D
- Telefonszám: +91 9652104726
- E-mail: abdulrasheedmd1223@gmail.com
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Kapcsolatba lépni:
- Rupjyoti Talukdar, MD
- Telefonszám: +91 7032804231
- E-mail: rup_talukdar@yahoo.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
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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.
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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.
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Painless Chronic Pancreatitis
Patients diagnosed with chronic pancreatitis who do not experience abdominal pain, serving as a disease control group
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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.
|
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Healthy Controls
Age- and sex-matched individuals without any pancreatic or systemic diseases, serving as a healthy control group
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Role of Central Sensitization
Időkeret: At the time of the single study visit
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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
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At the time of the single study visit
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Brain Connectivity
Időkeret: At the time of the single study visit.
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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
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At the time of the single study visit.
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Brain Metabolites
Időkeret: At the time of the single study visit.
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Quantification of brain metabolites in key brain regions using magnetic resonance spectroscopy
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At the time of the single study visit.
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Quantification of Blood-Based Metabolites
Időkeret: At the time of the single study visit.
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Quantification of blood-based metabolites to identify potential biomarkers associated with pain phenotypes in patients with chronic pancreatitis.
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At the time of the single study visit.
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Együttműködők és nyomozók
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Neurológiai megnyilvánulások
- Idegrendszeri betegségek
- Patológiás folyamatok
- Krónikus betegség
- Betegség tulajdonságai
- Emésztőrendszeri betegségek
- Neuroviselkedési megnyilvánulások
- Hasnyálmirigy-betegségek
- Percepciós zavarok
- Kóros állapotok, jelek és tünetek
- Jelek és tünetek
- Hasnyálmirigy-gyulladás
- Fájdalom
- Pancreatitis, krónikus
- Agnosia
- Diagnosztikai technikák és eljárások
- Diagnózis
- Tomográfia
- Diagnosztikai képalkotás
- Kép-értelmezés, számítógéppel segített
- Képjavítás
- Fényképezés
- Tomográfia, kibocsátási számú
- Radionuklid képalkotás
- Diagnosztikai technikák, radioizotóp
- Pozitron emissziós tomográfia
Egyéb vizsgálati azonosító számok
- NACP1
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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