BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone/muscle in Children with Cerebral Palsy (BIODETECT_CP)

November 1, 2024 updated by: IRCCS Fondazione Stella Maris

BIODETECT_CP a Novel Combination of BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone/muscle Unit Health in Children with Cerebral Palsy

Cerebral palsy (CP) is the most common chronic disability in childhood, burden by motor, sensation, cognition, feeding and communication impairment. A serious concern in children with CP is bone/muscle health deterioration, which negatively impacts the already reduced quality of life (QoL). Children with CP show low bone density, vitamin D deficiency, sarcopenia and high risk of fragility fractures, with heavy effects on what is already limited home, school and community life. The causes for muscle-bone impairment are low weight-bearing deambulation during skeletal formation with low bone mineralization, poor nutrition and low calcium intake, low sun exposure, use of anticonvulsant medications with a negative profile on bone. Understanding the causes affecting bone quality and setting up interventions to reduce the impact of physical disability are essential in young subjects with CP.

This project combines complementary expertise and resources in the fields of Endocrinological Biochemistry, Paediatric Neurological Disorders and Neuroimaging, to allow an innovative, technology-assisted workup for bone/muscle health evaluation in young subjects with CP, which could drive novel therapeutics, nutritional and rehabilitation programs.

The first aim of this project is to evaluate bone/muscle health in young subjects with CP compared with sex-age matched healthy subjects, providing i) serum biomarkers of mineral metabolism and the metabolome of Vitamin D, assessed with last generation Mass Spectrometry, ii) muscle sarcopenia markers like Irisin and other myokines, depicting the response of the muscle to exercise iii) neuronal damage and inflammatory markers, iv) densitometric data by the low-cost and safe Quantitative ultrasound (QUS) at phalanges of the hand, plus the novel and very promising Radiofrequency Echographic Multi Spectrometry (REMS) served by the software for fragility fractures risk.

We also aim to correlate the previous mentioned markers of bone/muscle health with a combination of demographic, clinical, cognitive and technological parameters, the last obtained by an innovative use of wearable sensors or actigraphs, positioned at the wrists, which depicts movements, physical activity (PA), energy expenditures (EE) and, together with heart-rate monitors, metabolic data during a normal like week in subjects with CP and healthy controls. Finally, a newly validated scoring for brain lesions in subjects with CP and the production of imaging "biomarkers" of neuronal damage, will be correlated with their bone/muscle health data, PA and EE to understand the impact of brain damage on functional performance and bone metabolism.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study investigates the correlation between brain lesions, physical ability, and bone/muscle health in young patients with cerebral palsy (CP). It posits that:

Bone and muscle health in young individuals with CP is compromised, affecting their quality of life and development. The study aims to utilize biomarkers related to bone fragility, sarcopenia, and neuronal damage, alongside advanced imaging techniques (quantitative ultrasound and Radiofrequency Echographic Multi Spectrometry) to assess bone/muscle unit health accurately.

Physical activity limitations and reduced energy expenditure negatively impact bone/muscle health in CP patients. The researchers plan to leverage wearable sensors to provide precise measurements of physical activity and correlate these with the established biomarkers and imaging results, aiding in customized treatment approaches.

Brain MR imaging could reveal structural changes in the brain, which may correlate with physical activity and bone/muscle health data, helping to understand the implications of brain damage on overall functionality.

The objectives include comparing bone/muscle health between children with CP and healthy peers, assessing physical activity's impact on bone/muscle health, and analyzing brain imaging results in relation to those health metrics. The study anticipates enrolling 50 participants with CP and 50 age-matched controls, utilizing various biochemical and imaging techniques to gather and compare data on bone and muscle health, physical activity, and brain lesions.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age
  • willing to sign inform content

Exclusion Criteria:

  • bisphosphonates or bone diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with cerebral palsy
50 children with cerebral palsy in whom the intervention is intended as the application of already validated movement sensors, namely actigraphs.
Diagnostic test: REMS: Radiofrequency Echographic Multi Spectrometry
it is a non invasive ultrasonographic evaluation of bone and muscle quality
Active Comparator: Typically developing children
50 healthy children, evaluated c/o AOUP for the exclusion of other diseases, in whom for intervention is intended the application of already validated movement sensors.
Diagnostic test: REMS: Radiofrequency Echographic Multi Spectrometry
it is a non invasive ultrasonographic evaluation of bone and muscle quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone/Muscle Unit Health Assessment
Time Frame: at enrollment

We will achieve the aim 1 by the following evaluations:

- 25OHD changes evaluated as plasma levels of Vitamin D, intended as hypovitaminosis D 25OHD<20 ng/ml
at enrollment
Evaluation of bone mineral density as QUS
Time Frame: at enrollment
AD-SOS (amplitude-dependent speed of sound) expressed as standard deviation compared to normal (absolute number) and BTT (bone transmission time expressed in seconds)
at enrollment
Evaluation of bone/muscle score at REMS
Time Frame: at enrollment
T score and Z score at REMS are index of bone fagility and are expressed as standard deviation difference compared to normal (absolute number, cut off <2.5). Moreover a % of fragility risk is produced (cut-off >10%)
at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Fondazione Stella Maris

Collaborators

University of Pisa
Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIN2022
  • PRIN2002 (Other Grant/Funding Number: Italian Ministry of Education)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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