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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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.

Detailed Summary:

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.

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.