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

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.

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Key information

Conditions

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

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UTexasSouthwestern

Dallas, Texas, 75235, United States

About this study

Both parent and child will participate in the online questionnaires. The validated questionnaires, PROMIS or Patient-Reported Outcomes Measurement Information System, are blocks of 8-10 questions. 7 blocks of questions for the parent and 7 similar blocks for the child: anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships, upper extremity function.

Participation via the Internet: When a child or family enters the Transverse Myelitis Association (TMA) website, they will be directed to information about the CAPTURE study. If the family is interested in participation, the TMA will give them the UT southwestern in Dallas, TX research coordinator information. It is up to the parent/guardian to contact the study staff from University Texas Southwestern. Once initial contact is complete, at the family's request, study staff will send the consent form to the interested family. The family will need to email or mail the consent back. Once the signed consent form is in hand, we will send the research survey to the email the parent provides. One survey for the parent, a separate but similar survey for a school aged child.

We will invite parents of school aged children to complete a school survey. This is a one time only questionnaire. Ideally, the parents will complete this either 6 months or 1 year into their child's recovery of TM/AFM.

We invite families living outside of North America to participate in the online survey. They need to be fluent in English, same as the North American cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the registry:

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

Exclusion criteria

for the registry:

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

Treatment and study plan

Primary outcomes

Patient and parent reported symptoms of recovery

Time frame: up to one year post symptom onset

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.

Secondary outcomes

ASIA scale

Time frame: up to one year after symptom diagnosis

We will measure the motor (movement) and sensory (touch) of the child above and below the spinal lesion. This is completed at 3 time points 3,6,and 12 months post symptom onset. For the secondary outcomes, the family needs to be able to travel to 1 of the 5 centers listed in the study.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

Patient-Centered Outcomes Research Institute

Registry information

Acronym: TMCAPTURE

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: May 22, 2014
Registry last updated: Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed