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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 : Unknown
Verified September 2016 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : May 22, 2014
Last Update Posted : September 26, 2016
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Children's Hospital of Philadelphia
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Children's Hospital Colorado
Children's Hospital Medical Center, Cincinnati
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. Their options are to join the data repository only, or participate in a clinical sub study in conjunction with the database repository. The data generated in this study will come from surveys, interviews, review of medical records, and physical examinations.

Data from this study will be utilized to guide future clinical trials for children with an acute case of Transverse Myelitis. Parents and children separately will fill out an online data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will have both the parent and child fill out at time of symptom onset, and three time points to follow, 3, 6, and 12 months post symptom onset.

A small subset of patients filling out the data registry will be able to travel to 1 of 5 treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia, Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins University in Baltimore, MD for a physical examination highlighting recovery from Transverse Myelitis.


Condition or disease
Myelitis, Transverse

Detailed Description:

There are two ways a child can be enrolled in this study, face to face and via internet. Both cohorts 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.

Face to face: A face to face substudy will be completed at time of diagnosis or base line and 3 months if able to complete. And again at 6 and 12 months post diagnosis. For the sub study in person study, children will undergo several outcomes measures highlighting physical mobility. These outcomes will be completed at their regularly scheduled follow up visit. There may be a case of a family electing to come to clinic as a research participant only. Those rare cases will undergo the same online questionnaire and come to the Neurology clinic at Children's Medical Center Dallas.

Via 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 CMCD research coordinator information. It is up to the parent/guardian to contact the CRC from CMCD. 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 can give a user name and password for the online study. We will send reminders to complete the 3 month, if applicable and the 6,12 month questionnaires to the contact of the family's choosing: email, postal service, or telephone.

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.

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


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 : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
myelitis, transverse
Observational study with two groups or cohorts: online survey participation and in person physical examination with survey participation. The surveys can be completed by the child and parent, or if too young to participate, parent only. The survey asks about how the child is doing 3.6 and 1 year after diagnosis.



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.


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. The diagnosis of TM needs to be within 3 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

Inclusion Criteria for clinical sub study:

  • All inclusion for the registry study
  • Ability to have clinic visits 3 months ,6 months and 12 months post symptom onset

Exclusion Criteria for clinical sub study:

  • All exclusion criteria for the registry study
  • Inability to take part in clinical assessments

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

Locations
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
Children's Hospital of Philadelphia
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Children's Hospital Colorado
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Benjamin Greenberg, MD UT Southwestern

Additional Information:
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: September 26, 2016
Last Verified: September 2016
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:
Myelitis
Myelitis, Transverse
Central Nervous System Infections
Central Nervous System Diseases
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