The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Study Overview
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Brief Summary
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This study seeks to determine the biologic causes of inflammation in patients with Transverse Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Detailed Description
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This study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO), Transverse Myelitis (TM), optic neuritis (ON), related conditions and healthy controls. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions. Patients will agree to share medical records, complete questionnaires and donate samples on a timed basis.

Official Title
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Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Conditions
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Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 years or greater Male or Female Patient or Parent (in the case of a minor) able to give informed consent For patients 10 to 17, patient able to assent Patient diagnosed with NMO, NMOSD, TM or ON Exclusion Criteria: Unable to maintain scheduled visits Patient has known HIV or hepatitis C infection

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuromyelitis Optica Spectrum Disorder<br>Patients diagnosed with NMOSD based on revised diagnostic criteria. Seronegative, anti-AQP4 seropositive and ant-MOG seropositive patients will be included | |
| Transverse Myelitis and Optic Neuritis<br>Patients who have had one demyelinating event, not diagnosed with multiple sclerosis and whom are considered at risk for NMO or NMOSD. | |
| Healthy Controls<br>patients without a history of CNS inflammation | |
| Neuromyelitis Optica<br>patients diagnosed with NMO | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure change in standard clinical assessments over time | Standard clinical assessments include: relapse information, level of disability based on EDSS score, high and low contract visual acuity, ambulation index, optical coherence tomography, and MRI, and neurologic/physical exam | Every study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure change in cognition measures over time | Cognition measures include the SDMT, JLO, and PASAT | Every study visit | 
| Measure change in self-reported quality of life surveys | Surveys include MSNQ, MSQOL-54, QIDS, BDI-II, FSS, ESS, MFIS, BPI, and Neuro-QoL | Every study visit | 
| B cell population changes | Measure B cell subtypes and changes over time | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis, Biorepository