Functional Connectome in Prader-Willi Syndrome: Neuroimaging and AI to Assess Therapeutic Impact
NCT ID: NCT06900335
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2025-03-01
2025-03-15
Brief Summary
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* How are brain connectivity patterns altered in PWS patients compared to healthy and obese controls?
* How do brain network changes relate to hyperphagia and the response to growth hormone therapy?
Researchers 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.
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Detailed Description
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This 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.
fMRI data has been obtained before and after meals, and/or before and after one year of growth hormone therapy.
Data 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.
Regarding 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.
Finally, 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.
With 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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients with PWS
Adult (\>18 y.o.) patients with genetically confirmed diagnosis of Prader-Willi syndrome.
GH treatment (Somatropin)
Treatment with Somatropin (recombinant GH), with doses starting from 0.2 mg/day and adjusted as necessary.
Eating
Allowing patients to break fasting.
Healthy controls
Age and sex matched healthy controls
Eating
Allowing patients to break fasting.
Obese controls
Age and sex matched controls with obesity (BMI \> 30)
Eating
Allowing patients to break fasting.
Interventions
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GH treatment (Somatropin)
Treatment with Somatropin (recombinant GH), with doses starting from 0.2 mg/day and adjusted as necessary.
Eating
Allowing patients to break fasting.
Eligibility Criteria
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Inclusion Criteria
* Age older than 18 years old.
Exclusion Criteria
* Contraindications for fMRI.
* Visual defects.
18 Years
ALL
Yes
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Assumpta Caixas
Principal Investigator
Locations
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Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Countries
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Other Identifiers
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2025/5022
Identifier Type: -
Identifier Source: org_study_id
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