Sensation, Motion, and Quality of Life on Natalizumab and Off Natalizumab
NCT05172466 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2022-11-25
Summary
The goal of this proposal is to use the BeCare App to (1) determine changes in "Feel Good Effect", or "Restoring Physiologic Homeostasis(RPH)"for individuals with relapsing-remitting MS (RRMS) before and after starting Natalizumab therapy and (2) Compare BeCare-derived with clinically-derived performance metrics.
Conditions
- Relapsing-remitting Multiple Sclerosis (RRMS)
Interventions
- DEVICE
-
BeCare application
Participants will complete activities on the application 3 times a week for 2 weeks when they first join the study. They will then attend 4 in-person visits where they complete clinical and application based assessments. Activities are clearly marked in the application and participants are assigned specific assessments by the study team. The application analyzes user input during each evaluation to provide an outcome measure for that assessment.
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Laura Tabacof, MD · Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-31
- Primary Completion
- 2022-11-11
- Completion
- 2022-11-11
Countries
- United States
Study Locations
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