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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02144935
Other study ID # 012014-077
Secondary ID 012014-077
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date August 19, 2022

Study information

Verified date August 2022
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date August 19, 2022
Est. primary completion date August 19, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States UTexasSouthwestern Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient and parent reported symptoms of recovery 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. up to one year post symptom onset
Secondary ASIA scale 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. up to one year after symptom diagnosis
See also
  Status Clinical Trial Phase
Terminated NCT02398994 - A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis Phase 3
Completed NCT00304291 - A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease) Phase 4