Clinical trial NCT02144935: Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study
Official title: Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelitis, Transverse
Flaccid Paraplegia, Complete, Acute
Flaccid Paraplegia, Incomplete, Acute
Keywords: pediatrics
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-05-22
Enrollment: 106
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient and parent reported symptoms of recovery
timeFrame: up to one year post symptom onset
Secondary outcomes:
measure: ASIA scale
timeFrame: up to one year after symptom diagnosis
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTexasSouthwestern
state: Texas
Study officials:
affiliation: UT Southwestern
name: Benjamin Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: