Neuromuscular DiseasesNCT02253290
Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease
An observational study of Neuromuscular Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuromuscular Diseases
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Apr 2025
- How long will I take part?
- 18 Years
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children and adolescents with neuromuscular disease
Who may be able to join
- children and adolescents (0-18 years)
- diagnosis of neuromuscular disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
sam Geuens, sam.geuens@uzleuven.be
About this study
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.
Read the detailed description
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease. Children and adolescents in UZ Leuven will be evaluated according to a psychosocial and neuropsychological protocol including different psychological tests and patient questionaires.
- Conditions
- Neuromuscular Diseases
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular disease | Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological profile (questionnaires, neuropsychological testing) of children with myotonic dystonia type 1
Compare the outcome of the questionnaires, IQ test and other neuropsychological test to a normal population
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Goemans, MD, PhD, Principal investigator, UZ LeuvenLiesbeth De Waele, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253290
- Sponsor's protocol ID
- S57182
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2014
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease
- ClinicalTrials.gov ID
- NCT02253290
- Acronym / sponsor ID
- S57182
- Conditions
- Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- 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.
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.
Detailed description
This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease. Children and adolescents in UZ Leuven will be evaluated according to a psychosocial and neuropsychological protocol including different psychological tests and patient questionaires.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular disease | – | –Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children and adolescents with neuromuscular disease
Key inclusion criteria (2 listed)
- children and adolescents (0-18 years)
- diagnosis of neuromuscular disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropsychological profile (questionnaires, neuropsychological testing) of children with myotonic dystonia type 1
Time frame: one year
Compare the outcome of the questionnaires, IQ test and other neuropsychological test to a normal population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Nathalie Goemans, MD, PhD principal investigator
UZ Leuven
Liesbeth De Waele, MD, PhD principal investigator
UZ Leuven
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 Neuromuscular Diseases, run by Universitaire Ziekenhuizen KU Leuven 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Geuens, Master (+32 16 34 19 91, sam.geuens@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological profile (questionnaires, neuropsychological testing) of children with myotonic dystonia type 1 (time frame: one year). 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 3 Jul 2024.