The MS-LINK Outcomes Study is a patient-focused registry that seeks to gather information to help make healthcare advancements for the benefit of people with MS. Participants in the MS-LINK Outcomes Study will share information about their demographics, MS history, treatments, and respond to monthly surveys about their symptoms and management. They will also allow their neurologist to share information contained in the medical records about their MS-related visits, lab and MRI results, and care plan. The information collected will be de-identified so that individual privacy is respected. By capturing a large amount of patient-centered data while using data-sharing technology, we will better understand the effects that MS and MS treatments truly have on people’s lives.

We plan to enroll 200 participants at UT Health Austin during the three-year period of this study.

Inclusion Criteria

• Adults aged >18 years of age diagnosed with MS, treated and untreated, by MS Centers in the US and Canada
• Willing and able to provide written informed consent
• Willing to be contacted for recruitment into sub-studies that may be relevant to them
• Willing and able to complete monthly surveys and document events of interest (e.g., MRI, relapse, hospitalization, and ER/urgent care visits) as they occur
• Willing to participate in additional follow up (no additional visits outside of routine care required) at the site for at least three years

Exclusion Criteria

• Unable to complete questionnaires in English
• Unable to consistently access the Internet
• Patients participating in clinical drug trials at the time of study enrollment

Clinical Trial Information

https://clinicaltrials.gov/ct2/show/NCT04735406

Status: Recruiting

The MS-LINK Outcomes Study at the University of Texas at Austin
Location: UT Health Austin, MS and Neuroimmunology Center
Dell Medical School
Local site principal investigator: Leorah Freeman, MD, PhD
Research coordinators: Helen Onuorah, BA; Avery Largent, BA
Contact: mslinkoutcomes@austin.utexas.edu

Sponsor
EMD Serono
Contact: US Medical Information, 888-275-7376, eMediUSA@emdserono.com; Communication Center, +49 6151 72 5200, service@emdgroup.com

The CAVS-MS study seeks to answer whether the Central Vein Sign can be used as a sensitive and specific diagnostic marker for a diagnosis of MS. The study will investigate the Central Vein Sign using MRI in a mixed population of participants presenting for a suspected diagnosis of MS with typical clinical presentations and atypical presentations including radiological presentations without neurological symptoms.

We will follow study participants for up to 24 months to determine the specificity and sensitivity of the Central Vein Sig for a diagnosis of MS using the 2017 McDonald Criteria.

Inclusion Criteria

• Age 18 to 65 inclusive
• Referral to a study academic site for a clinical suspicion of MS
• Onset with typical or atypical presentations of MS
• Able to provide written informed consent to participate in the study
• For participants referred for clinical suspicion of multiple sclerosis who had workup prior to referral or who are taking disease-modifying therapies for MS, digital availability of diagnostic cranial MRI with gadolinium within 3 months of initial symptoms
• Onset of typical neurological symptoms within 10 years of screening.

Exclusion Criteria

• Contraindication to MRI studies; metal or metal implants incompatible with MRI
• Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g.tremor)
• Contraindication to use of gadolinium containing contrast agents (allergy or renal failure)
• Treatment with systemic corticosteroids in the 4 weeks preceding enrollment

Clinical trial information

https://www.clinicaltrials.gov/ct2/show/NCT04495556

IRB Study Number 17-976

Status Not yet recruiting

CAVS-MS at the University of Texas at Austin
Location: UT Health Austin, MS and Neuroimmunology Center
Dell Seton Medical Center
Local site principal investigator: Leorah Freeman, MD, PhD
Research coordinators: Sarah Campbell, RN; Helen Onuorah, BA
Contact: ms.io@austin.utexas.edu

Sponsor
The Cleveland Clinic
Principal Investigators: Dan Ontaneda, MD, The Cleveland Clinic
Nancy Sicotte, MD, Cedars-Sinai Medical Center
Contact: Praneeta C Raza, MD, MSc 216-445-9692 razap@ccf.org