Neuropsychological and Psychosocial Follow up of Children... | NCT02253290

Studies
Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease

NCT02253290

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jul 3, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Neuromuscular Diseases

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014Actual

Primary Completion Date

Apr 2025Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 26, 2014

First Posted Date

Oct 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuromuscular disease		Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

children and adolescents (0-18 years)
diagnosis of neuromuscular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children and adolescents with neuromuscular disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sam Geuens, Master	Contact	+32 16 34 19 91		sam.geuens@uzleuven.be

Overall Officials

Name	Affiliation	Role
Nathalie Goemans, MD, PhD	UZ Leuven	Principal Investigator
Liesbeth De Waele, MD, PhD	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven	Recruiting	Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D009468	Neuromuscular Diseases

Ancestor Terms

ID	Term
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided