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

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ClinicalTrials.gov Identifier: NCT02144935
Recruitment Status : Recruiting
First Posted : May 22, 2014
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.


Condition or disease
Myelitis, Transverse Flaccid Paraplegia, Complete, Acute Flaccid Paraplegia, Incomplete, Acute

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study
Study Start Date : May 2014
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144935


Contacts
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Contact: Tricia Plumb, RN, MSN 214-456-2464 patricia.plumb@utsouthwestern.edu
Contact: Ben Greenberg, MD 214-645-0555 benjamin.greenberg@utsouthwestern.edu

Locations
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United States, Texas
UTexasSouthwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Tricia Plumb, RN, MSN    214-456-2464    patricia.plumb@utsouthwestern.edu   
Contact: Ben Greenberg, MD    214-645-0555    benjamin.greenberg@utsouthwestern.edu   
Principal Investigator: Benjamin Greenberg, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Benjamin Greenberg, MD UT Southwestern

Additional Information:
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02144935     History of Changes
Other Study ID Numbers: 012014-077
012014-077 ( Other Identifier: UTSW IRB )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Texas Southwestern Medical Center:
pediatrics
Additional relevant MeSH terms:
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Myelitis, Transverse
Paraplegia
Myelitis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Neurodegenerative Diseases
Autoimmune Diseases
Immune System Diseases