Cerebral PalsyNCT05060211
Incontinence and MRI Results in Children with Cerebral Palsy
An observational study of Cerebral Palsy and Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
More than 50 % of children and adults with cerebral palsy experience lower urinary tract symptoms (LUTS). This can negatively influence quality of life of the child and the total social environment. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy, Lower Urinary Tract Symptoms
- What is being tested?
- Vancouver symptom score for dysfunctional elimination syndroms and Magnetic resonance imaging
- How many people
- 125 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Oct 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cerebral palsy attending yearly or half yearly follow-up consultation
Who may be able to join
- Diagnosis of cerebral palsy
- MRI investigation in history
- Dutch or French speaking child and parent
Who cannot join
- No MRI investigation in history
- Child or parent not speaking Dutch or French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Brain Lesion and Continence in Children with Cerebral Palsy: an Anatomical MRI Study
More than 50 % of children and adults with cerebral palsy experience lower urinary tract symptoms (LUTS). This can negatively influence quality of life of the child and the total social environment.
Previous research demonstrated that the brain lesion, characteristic for cerebral palsy (CP), is a prognostic factor for the functional abilities of a child with CP. Previous research within our department demonstrated functional impairment as a risk factor for incontinence. This demonstrates an indirect connection between the brain lesion and incontinence of a child with CP. However, this connection isn't alway correct as some children with high functionality also demonstrate incontinence.
As bladder control is also regulated by higher brain centers, the present study wants to investigate a direct connection between the brain lesion of the child, visible by means of MRI, and the incontinence status of the child. .
Read the detailed description
The current study is a cross-sectional observational study in which a correlation is investigated between known anatomical MRI results and the continence status of a child with CP.
Although neuroimaging isn't seen as a requirement for the definition and diagnosis of CP2, MRI imaging is often part of diagnostic evaluation. The Surveillance of Cerebral Palsy in Europe (SCPE) working group composed the MRI classification system or MRICS classifying neuroimaging results in maldevelopments, predominant white matter injury, predominant grey matter injury, miscellaneous and normal. These results will be correlated with results of the validated Vancouver symptoms score for dysfunctional elimination syndrome.
- Conditions
- Cerebral Palsy, Lower Urinary Tract Symptoms
- Being tested
- Vancouver symptom score for dysfunctional elimination syndroms, Magnetic resonance imaging
- Keywords
- cerebral palsy, lower urinary tract symptoms, Magnetic resonance imaging, brain lesion, incontinence
- Medical subject headings
- Cerebral Palsy, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancouver symptom score for dysfunctional elimination syndromsOther
Also called VSSDES
Validated questionnaire concerning bladder and bowel symptoms
Magnetic resonance imagingOther
Also called MRI
Known MRI results of the patient file
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence ratio
Amount of patients with incontinence in the different MRICS-groups (MRI classification system for children with CP).
Measured: During cross-sectional testing
Secondary outcomes (2)
Amount of Lower urinary tract symptoms in different MRICS-groups
Score of 'Vancouver symptom score for dysfunctional elimination syndrome'-questionnaire and individual questions in the different MRICS- groups (MRI classification system for children with CP).
Measured: During cross-sectional testing
Amount of bladder symptoms in different MRICS-groups
Score of individual questions from the 'Vancouver symptom score for dysfunctional elimination syndrome' questionnaire in the different MRICS- groups (MRI classification system for children with CP).
Measured: During cross-sectional testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start25 Oct 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Bieke Samijn, dr., Principal investigator, Ghent University Hospital/Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060211
- Sponsor's protocol ID
- B6702021000735
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Brain Lesion and Continence in Children with Cerebral Palsy: an Anatomical MRI Study
- ClinicalTrials.gov ID
- NCT05060211
- Acronym / sponsor ID
- B6702021000735
- Conditions
- Cerebral Palsy, Lower Urinary Tract Symptoms
- Keywords
- cerebral palsy, lower urinary tract symptoms, Magnetic resonance imaging, brain lesion, incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Sep 2021 (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.
More than 50 % of children and adults with cerebral palsy experience lower urinary tract symptoms (LUTS). This can negatively influence quality of life of the child and the total social environment.
Previous research demonstrated that the brain lesion, characteristic for cerebral palsy (CP), is a prognostic factor for the functional abilities of a child with CP. Previous research within our department demonstrated functional impairment as a risk factor for incontinence. This demonstrates an indirect connection between the brain lesion and incontinence of a child with CP. However, this connection isn't alway correct as some children with high functionality also demonstrate incontinence.
As bladder control is also regulated by higher brain centers, the present study wants to investigate a direct connection between the brain lesion of the child, visible by means of MRI, and the incontinence status of the child. .
Detailed description
The current study is a cross-sectional observational study in which a correlation is investigated between known anatomical MRI results and the continence status of a child with CP.
Although neuroimaging isn't seen as a requirement for the definition and diagnosis of CP2, MRI imaging is often part of diagnostic evaluation. The Surveillance of Cerebral Palsy in Europe (SCPE) working group composed the MRI classification system or MRICS classifying neuroimaging results in maldevelopments, predominant white matter injury, predominant grey matter injury, miscellaneous and normal. These results will be correlated with results of the validated Vancouver symptoms score for dysfunctional elimination syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cerebral palsy attending yearly or half yearly follow-up consultation
Key inclusion criteria (3 listed)
- Diagnosis of cerebral palsy
- MRI investigation in history
- Dutch or French speaking child and parent
Key exclusion criteria (2 listed)
- No MRI investigation in history
- Child or parent not speaking Dutch or French
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 |
|---|---|---|
| Vancouver symptom score for dysfunctional elimination syndromsAlso: VSSDESValidated questionnaire concerning bladder and bowel symptoms | Other | – |
| Magnetic resonance imagingAlso: MRIKnown MRI results of the patient file | Other | – |
Primary outcome
Incontinence ratio
Time frame: During cross-sectional testing
Amount of patients with incontinence in the different MRICS-groups (MRI classification system for children with CP).
2 secondary outcomes
Amount of Lower urinary tract symptoms in different MRICS-groups
Time frame: During cross-sectional testing
Amount of bladder symptoms in different MRICS-groups
Time frame: During cross-sectional testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Bieke Samijn, dr. principal investigator
Ghent University Hospital/Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence ratio (time frame: During cross-sectional testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.