Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 5:21 AM
Study NCT ID:
NCT06900335
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Connectome in Prader-Willi Syndrome: Neuroimaging and AI to Assess Therapeutic Impact
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'D004435', 'term': 'Eating'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Neuroimages of fMRI.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional connectivity patterns', 'timeFrame': 'Before and after the intervention (immediately after the end of the intervention for hunger, up to a year for GH).', 'description': 'Brain connectivity patterns, particularly those related to hyperphagia and the response to growth hormone therapy in the case of PWS patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroimage', 'Artificial Intelligence', 'Prader-Willi Syndrome'], 'conditions': ['Prader Willi Syndrome', 'Hyperphagia', 'Behavior Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore brain network changes and identify patterns related to hyperphagia, hormonal treatment effects, and cognitive deficits in adults with Prader-Willi Syndrome (PWS). The main questions it aims to answer are:\n\n* How are brain connectivity patterns altered in PWS patients compared to healthy and obese controls?\n* How do brain network changes relate to hyperphagia and the response to growth hormone therapy?\n\nResearchers will compare PWS patients to healthy and obese controls to see if there are significant differences in brain network connectivity before and after meals and growth hormone therapy. Ultimately, researchers will try to develop predictive models of treatment outcomes using AI and machine learning.', 'detailedDescription': 'Prader-Willi Syndrome (PWS) is a rare genetic condition marked by issues like constant hunger, obesity, hormonal imbalances, and cognitive difficulties. While studies have shown changes in brain connectivity in PWS patients, a complete understanding of these changes is still lacking. This project aims to explore brain network patterns in PWS using advanced AI techniques to better understand the impact of hyperphagia, hormonal treatments, and cognitive challenges.\n\nThis study will combine data from brain functional magnetic ressonance imaging (fMRI)), genetic data, hormonal levels, and clinical details; of 39 adults with PWS and 82 control participants (including 52 healthy and 30 obese controls). All participants are matched for age, sex, and BMI where applicable.\n\nfMRI data has been obtained before and after meals, and/or before and after one year of growth hormone therapy.\n\nData quality will be assessed and summarize it using averages or percentages. Then, groups will be statistically compared to detect patterns related to hyperphagia and GH therapy.\n\nRegarding Brain Connectivity, data from patients and controls will be compared, tracking how brain networks change after meals/GH therapy and applying advanced statistical methods to control errors.\n\nFinally, using AI, models to predict treatment outcomes and brain network changes will be developed. These models will be tested and refined using different techniques to ensure reliability.\n\nWith this research, expected results are to identify unique brain patterns in PWS, uncover how these relate to symptoms like hyperphagia, and develop AI models to predict treatment outcomes. Ultimately, this research aims to improve our understanding of PWS and help develop better treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (\\>18 y.o.) patients with PWS were selected from a cohort of patients who receive medical attention and follow-up at our hospital. Controls were also selected from hospital patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetically confirmed diagnosis of Prader-Willi Syndrome.\n* Age older than 18 years old.\n\nExclusion Criteria:\n\n* Age younger than 18 years old.\n* Contraindications for fMRI.\n* Visual defects.'}, 'identificationModule': {'nctId': 'NCT06900335', 'briefTitle': 'Functional Connectome in Prader-Willi Syndrome: Neuroimaging and AI to Assess Therapeutic Impact', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Characterization of the Functional Connectome in Prader-Willi Syndrome: Integrating Neuroimaging and Artificial Intelligence to Assess the Impact of Physiological and Therapeutic Interventions', 'orgStudyIdInfo': {'id': '2025/5022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with PWS', 'description': 'Adult (\\>18 y.o.) patients with genetically confirmed diagnosis of Prader-Willi syndrome.', 'interventionNames': ['Drug: GH treatment (Somatropin)', 'Behavioral: Eating']}, {'label': 'Healthy controls', 'description': 'Age and sex matched healthy controls', 'interventionNames': ['Behavioral: Eating']}, {'label': 'Obese controls', 'description': 'Age and sex matched controls with obesity (BMI \\> 30)', 'interventionNames': ['Behavioral: Eating']}], 'interventions': [{'name': 'GH treatment (Somatropin)', 'type': 'DRUG', 'description': 'Treatment with Somatropin (recombinant GH), with doses starting from 0.2 mg/day and adjusted as necessary.', 'armGroupLabels': ['Patients with PWS']}, {'name': 'Eating', 'type': 'BEHAVIORAL', 'description': 'Allowing patients to break fasting.', 'armGroupLabels': ['Healthy controls', 'Obese controls', 'Patients with PWS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08202', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Corporació Sanitària Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Assumpta Caixas', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}