COMPLETED

Assessment of Neurodevelopmental Needs in Duchenne Muscular Dystrophy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Duchenne Muscular Dystrophy is a genetic disease that causes progressive muscle weakness. There is now substantial evidence that boys with this disease do not demonstrate age-related gains in their cognitive skills. The goals of this study are (i) to use a technology-enabled neurobehavioral assessment called National Institutes of Health Toolbox Cognition Battery (NIHTB-CB) to assess brain development over time; (ii) engage with key-stakeholders to understand how neurodevelopmental problems like attention-deficit hyperactivity, autism spectrum affects individuals (and/or) families, so that we can understand meaningful effects of a potential treatment at an individual level, and (iii) to investigate using brain magnetic resonance imaging (MRI) changes in brain connectivity.

Official Title

Assessment of Neurodevelopmental Needs in Duchenne Muscular Dystrophy

Quick Facts

Study Start:2022-02-02
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05280730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Boys with confirmed genetic mutation in the dystrophin gene
  2. * Boys with clinical features of DMD and in whom muscle biopsy showed absence of dystrophin
  3. * Boys with clinical features of DMD and in whom there is a family history of DMD
  4. * Symptomatic carrier girls with DMD
  5. * Ages 3 and above at time of study screening
  1. * Care-giver unable to give consent
  2. * Any handicap that does not allow the ability to use an IPAD
  3. * For MRI, braces or any metal implants.

Contacts and Locations

Principal Investigator

Mathula Thangarajh, MD, PhD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Children's Hospital of Richmond
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Mathula Thangarajh, MD, PhD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2022-02-02
Study Completion Date2024-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Duchenne Muscular Dystrophy