Cerebral Palsy InfantileBIODETECT_CPNCT06672731
BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone/muscle in Children with Cerebral Palsy
A study testing REMS: Radiofrequency Echographic Multi Spectrometry in people with Cerebral Palsy Infantile, run by IRCCS Fondazione Stella Maris.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- REMS: Radiofrequency Echographic Multi Spectrometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age
- willing to sign inform content
Who cannot join
- bisphosphonates or bone diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy Infantile
- Being tested
- REMS: Radiofrequency Echographic Multi Spectrometry
- Keywords
- cerebral palsy, bone health, muscle health
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMS: Radiofrequency Echographic Multi SpectrometryDiagnostic test
it is a non invasive ultrasonographic evaluation of bone and muscle quality
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Experimental | 50 children with cerebral palsy in whom the intervention is intended as the application of already validated movement sensors, namely actigraphs. Receives: Diagnostic Test: REMS: Radiofrequency Echographic Multi Spectrometry |
| Typically developing children | Active comparator | 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. Receives: Diagnostic Test: REMS: Radiofrequency Echographic Multi Spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone/Muscle Unit Health Assessment
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
Measured: at enrollment
Evaluation of bone mineral density as QUS
AD-SOS (amplitude-dependent speed of sound) expressed as standard deviation compared to normal (absolute number) and BTT (bone transmission time expressed in seconds)
Measured: at enrollment
Evaluation of bone/muscle score at REMS
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%)
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672731
- Sponsor's protocol ID
- PRIN2022
- Other IDs
- PRIN2002
- Acronym
- BIODETECT_CP
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tinelli F, Guzzetta A, Purpura G, Pasquariello R, Cioni G, Fiori S. Structural brain damage and visual disorders in children with cerebral palsy due to periventricular leukomalacia. Neuroimage Clin. 2020;28:102430. doi: 10.1016/j.nicl.2020.102430. Epub 2020 Sep 11.
PubMed 32980597Di Paola M, Gatti D, Viapiana O, Cianferotti L, Cavalli L, Caffarelli C, Conversano F, Quarta E, Pisani P, Girasole G, Giusti A, Manfredini M, Arioli G, Matucci-Cerinic M, Bianchi G, Nuti R, Gonnelli S, Brandi ML, Muratore M, Rossini M. Radiofrequency echographic multispectrometry compared with dual X-ray absorptiometry for osteoporosis diagnosis on lumbar spine and femoral neck. Osteoporos Int. 2019 Feb;30(2):391-402. doi: 10.1007/s00198-018-4686-3. Epub 2018 Sep 4.
PubMed 30178159Tomai Pitinca MD, Fortini P, Gonnelli S, Caffarelli C. Could Radiofrequency Echographic Multi-Spectrometry (REMS) Overcome the Limitations of BMD by DXA Related to Artifacts? A Series of 3 Cases. J Ultrasound Med. 2021 Dec;40(12):2773-2777. doi: 10.1002/jum.15665. Epub 2021 Feb 21.
PubMed 33615539Baroncelli GI. Quantitative ultrasound methods to assess bone mineral status in children: technical characteristics, performance, and clinical application. Pediatr Res. 2008 Mar;63(3):220-8. doi: 10.1203/PDR.0b013e318163a286.
PubMed 18287958Colaianni G, Faienza MF, Sanesi L, Brunetti G, Pignataro P, Lippo L, Bortolotti S, Storlino G, Piacente L, D'Amato G, Colucci S, Grano M. Irisin serum levels are positively correlated with bone mineral status in a population of healthy children. Pediatr Res. 2019 Mar;85(4):484-488. doi: 10.1038/s41390-019-0278-y. Epub 2019 Jan 15.
PubMed 30683930Saggese G, Vierucci F, Prodam F, Cardinale F, Cetin I, Chiappini E, De' Angelis GL, Massari M, Miraglia Del Giudice E, Miraglia Del Giudice M, Peroni D, Terracciano L, Agostiniani R, Careddu D, Ghiglioni DG, Bona G, Di Mauro G, Corsello G. Vitamin D in pediatric age: consensus of the Italian Pediatric Society and the Italian Society of Preventive and Social Pediatrics, jointly with the Italian Federation of Pediatricians. Ital J Pediatr. 2018 May 8;44(1):51. doi: 10.1186/s13052-018-0488-7.
PubMed 29739471Braito I, Maselli M, Sgandurra G, Inguaggiato E, Beani E, Cecchi F, Cioni G, Boyd R. Assessment of upper limb use in children with typical development and neurodevelopmental disorders by inertial sensors: a systematic review. J Neuroeng Rehabil. 2018 Nov 6;15(1):94. doi: 10.1186/s12984-018-0447-y.
PubMed 30400992
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIODETECT_CP a Novel Combination of BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone/muscle Unit Health in Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06672731
- Acronym / sponsor ID
- BIODETECT_CP / PRIN2022
- Conditions
- Cerebral Palsy Infantile
- Keywords
- cerebral palsy, bone health, muscle health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- University of Pisa, Azienda Ospedaliero, Universitaria Pisana
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | Experimental | Diagnostic Test: REMS: Radiofrequency Echographic Multi Spectrometry50 children with cerebral palsy in whom the intervention is intended as the application of already validated movement sensors, namely actigraphs. |
| Typically developing children | Active comparator | Diagnostic Test: REMS: Radiofrequency Echographic Multi Spectrometry50 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age
- willing to sign inform content
Key exclusion criteria (1 listed)
- bisphosphonates or bone diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMS: Radiofrequency Echographic Multi Spectrometryit is a non invasive ultrasonographic evaluation of bone and muscle quality | Diagnostic test | Children with cerebral palsy, Typically developing children |
Primary outcome
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
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)
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%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 32980597Tinelli F, Guzzetta A, Purpura G, Pasquariello R, Cioni G, Fiori S. Structural brain damage and visual disorders in children with cerebral palsy due to periventricular leukomalacia. Neuroimage Clin. 2020;28:102430. doi: 10.1016/j.nicl.2020.102430. Epub 2020 Sep 11.
- Background: PubMed 30178159Di Paola M, Gatti D, Viapiana O, Cianferotti L, Cavalli L, Caffarelli C, Conversano F, Quarta E, Pisani P, Girasole G, Giusti A, Manfredini M, Arioli G, Matucci-Cerinic M, Bianchi G, Nuti R, Gonnelli S, Brandi ML, Muratore M, Rossini M. Radiofrequency echographic multispectrometry compared with dual X-ray absorptiometry for osteoporosis diagnosis on lumbar spine and femoral neck. Osteoporos Int. 2019 Feb;30(2):391-402. doi: 10.1007/s00198-018-4686-3. Epub 2018 Sep 4.
- Background: PubMed 33615539Tomai Pitinca MD, Fortini P, Gonnelli S, Caffarelli C. Could Radiofrequency Echographic Multi-Spectrometry (REMS) Overcome the Limitations of BMD by DXA Related to Artifacts? A Series of 3 Cases. J Ultrasound Med. 2021 Dec;40(12):2773-2777. doi: 10.1002/jum.15665. Epub 2021 Feb 21.
- Background: PubMed 18287958Baroncelli GI. Quantitative ultrasound methods to assess bone mineral status in children: technical characteristics, performance, and clinical application. Pediatr Res. 2008 Mar;63(3):220-8. doi: 10.1203/PDR.0b013e318163a286.
- Background: PubMed 30683930Colaianni G, Faienza MF, Sanesi L, Brunetti G, Pignataro P, Lippo L, Bortolotti S, Storlino G, Piacente L, D'Amato G, Colucci S, Grano M. Irisin serum levels are positively correlated with bone mineral status in a population of healthy children. Pediatr Res. 2019 Mar;85(4):484-488. doi: 10.1038/s41390-019-0278-y. Epub 2019 Jan 15.
- Background: PubMed 29739471Saggese G, Vierucci F, Prodam F, Cardinale F, Cetin I, Chiappini E, De' Angelis GL, Massari M, Miraglia Del Giudice E, Miraglia Del Giudice M, Peroni D, Terracciano L, Agostiniani R, Careddu D, Ghiglioni DG, Bona G, Di Mauro G, Corsello G. Vitamin D in pediatric age: consensus of the Italian Pediatric Society and the Italian Society of Preventive and Social Pediatrics, jointly with the Italian Federation of Pediatricians. Ital J Pediatr. 2018 May 8;44(1):51. doi: 10.1186/s13052-018-0488-7.
- Background: PubMed 30400992Braito I, Maselli M, Sgandurra G, Inguaggiato E, Beani E, Cecchi F, Cioni G, Boyd R. Assessment of upper limb use in children with typical development and neurodevelopmental disorders by inertial sensors: a systematic review. J Neuroeng Rehabil. 2018 Nov 6;15(1):94. doi: 10.1186/s12984-018-0447-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing REMS: Radiofrequency Echographic Multi Spectrometry in people with Cerebral Palsy Infantile, run by IRCCS Fondazione Stella Maris.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Federica Saponaro MD, PhD, Md, Phd (+393204964028, federica.saponaro@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone/Muscle Unit Health Assessment (time frame: at enrollment). The study lists 3 primary outcomes in all. 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 NCT06672731, which also lists 7 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 4 Nov 2024.