NCT02253290

Brief Summary

This project is a retrospective and prospective investigation of neuropsychological and psychosocial development of children with a neuromuscular disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

10.3 years

First QC Date

September 18, 2014

Last Update Submit

July 2, 2024

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Neuromuscular disease

Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children and adolescents with neuromuscular disease

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Nathalie Goemans, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

  • Liesbeth De Waele, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Geuens, Master

CONTACT

+32 16 34 19 91sam.geuens@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
18 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

October 1, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)