Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study

NCT02144935 | Completed

• 1 other identifier: 012014-077
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Patients and families are invited to participate in an online registry and data repository specifically for patients with transverse myelitis (TM) or acute flaccid myelitis (AFM). The data generated in this study will come from surveys, interviews, review of medical records. Data from this study will be utilized to guide future clinical trials for children with an acute case of TM or AFM. Parents and school aged children will complete an online survey 7 banks of questions. Each bundle of survey topics have 7-10 questions. We will have both the parent and child complete a outcomes based survey within 6 months of diagnosis and invite to participate every 4 months until study end in 2024.

Conditions

Myelitis, Transverse; Flaccid Paraplegia, Complete, Acute; Flaccid Paraplegia, Incomplete, Acute

Keywords

pediatrics

Outcome Measures

Primary Outcomes (1)

• Patient and parent reported symptoms of recovery

  each parent /guardian and child will fill out a questionnaire examining how you feel about your ability to move and your emotions. This is completed at 3,6,and 12 months after symptoms are diagnosed.

  up to one year post symptom onset

Secondary Outcomes (1)

• ASIA scale

  up to one year after symptom diagnosis

Study Arms (1)

myelitis, transverse or acute flaccid myelitis

Observational study with online survey participation highlighting outcomes recovery. The surveys can be completed by the child and parent, or if too young to participate, parent only. The survey asks how the child is doing after hospitalization within 6 months of diagnosis, and every 4 months until study end in 2024.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Transverse Myelitis. Pediatric Acute Flaccid Myelitis. The diagnosis of TM or AFM needs to be within 6 months of symptom onset at the time of consent.

You may qualify if:

• Diagnosis of transverse myelitis (TM) or acute flaccid myelitis (AFM)
• Patient is within 6 months of symptom onset
• Ability of patent or legal guardian is able to provide informed consent
• Ability of a child 10 or older able to provide assent
• Access to the internet

You may not qualify if:

• Inability to provide appropriate consent or assent
• Diagnosis of multiple sclerosis, neuromyelitis optica, or neuromyelitis optica spectrum disorder

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UTexasSouthwestern

Dallas, Texas, 75235, United States

Location

Related Links

• Transverse Myelitis Association

MeSH Terms

Conditions

Myelitis, Transverse; Paraplegia

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Demyelinating Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases; Immune System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin Greenberg, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 22, 2014
• Study Start: May 1, 2014
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)