Clinical trial NCT05172466: Sensation, Motion, and Quality of Life on Natalizumab and Off Natalizumab
Official title: Sensation, Motion, and Quality of Life on Natalizumab and Off Natalizumab
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)
Keywords: Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Mobile Applications
Natalizumab
Smartphone
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: Relapsing-remitting Multiple sclerosis (MS) is a chronic and often disabling disease that has been linked to a wide range of symptoms. Traditionally, MS-related symptoms have been evaluated using functional assessments such as the Kurtzke Expanded Disability Status Scale (EDSS) and the Timed Up and Go (TUG) Test. Detecting subtle changes in kinetic function is a key component in the monitoring and measuring of disease progression as well as predicting outcomes in MS. The BeCare Link mobile application provides validated, quantitative measurements of physical and cognitive functioning to give high precision measurement of disease status and treatment outcomes. Natalizumab is an effective drug that modulates immunity and inflammatory burden over time. While clinical outcomes in controlled clinical trials have shown that Natalizumab results in a reduction in disease progression on the EDSS, there is an often-referenced anecdotal effect reported by patients treated with Tysabri that they feel closer to their overall pre-MS sense of well-being, such as improved speed of cognition, reduced fatigue, and swifter motor and sensory function. This was named "Feel Good Effect", or "Restoring Physiologic Homeostasis(RPH)". Quantification of this effect has not been addressed previously.

This is a prospective single-center study. The goal of this proposal is to use the BeCare App to (1) determine changes in RPH for individuals with relapsing-remitting MS (RRMS) before and after starting Natalizumab therapy and (2) Compare BeCare-derived with clinically-derived performance metrics. Changes in RPH will be determined by pre/post differences in EDSS scores and self-reported questions regarding mood, quality of life, function and participation. The hypothesis is that Natalizumab will be associated with a significant improvement in RPH that will be quantifiable through the use of the BeCare App. The aim is to enroll 20 subjects, recruited from Mount Sinai MS clinic or self referred by contacting the study contact information posted on ClinicalTrials.gov. Individuals included will be of ages between 18 and 60 years with diagnosed RRMS (relapsing-remitting MS) who were prescribed Tysabri (Natalizumab) by their physician. Potential participants will contact the coordinator via phone call or e-mail and will be consented. After consent, participants will download the BeCare mobile application and be instructed to perform tasks on the app at their home 3 times per week for 2 weeks. Once they schedule their first Tysabri infusion, participants will come to 4 in-person study visits. At each visit, they will perform multiple application-based and clinically-based assessments. The entire study protocol will last up to 32 weeks, including follow up. All procedures of this trial are non-invasive and imply minimal risk. All study procedures involve clinical assessments performed routinely as part of their clinical care. Risks involve loss of private information and falling during the study tasks. Drug administration is not part of the trial, and it will be given as part of clinical care.

Each assessment is performed by the clinician once and the application once. These assessments include the Expanded Disability Status Scale (EDSS), Timed Up and Go (TUG), Tap Task, Path Test, Transcription Test, Timed 25-foot walk, Coded Message Cognitive Test, Six-minute walk test, Contrast sensitivity test, Arm elevation test, Memory test, Vibration test, and the Stroop color and word test (SCWT), 9 Whole Peg Test, Red Saturation Test and self-reported mood, quality of life, function, and participation.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis: RRMS (relapsing-remitting MS) or Multiple Sclerosis (Clinically Isolated Syndrome \[CIS\], Primary Progressive \[PPMS\], Secondary Progressive \[SPMS)
* Prescribed Tysabri (Natalizumab) or any other MS medication
* Natalizumab/Tysabri-naïve
* Ages 18-60
* Access to a smartphone\* \*In case a participant is ineligible due to lack of access to the technology, the study team will loan a tablet to participants for the duration of the study, free of charge. Participants will not be responsible for losing or damaging the device.

Exclusion Criteria:

* Inability to perform 5 or more of the BeCare App tasks independently
* EDSS \>6.5
* Corrective Visual Acuity lower than 20/200
* Any chronic illness that has not been stable for at least six months (medication changes during the past year for that condition are not exclusionary)
* Malignancy/previous chemotherapy treatment for neoplastic disease
* Untreated or unstable major depression or bipolar disease
* Clinical diagnosis: SPMS (Secondary-progressive multiple sclerosis) or PPMS (primary-progressive MS) 8. Acute COVID-19 infection with persisting symptoms for the last 6 weeks

Primary outcomes:
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Week 0 to 4
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Week 1-6
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Week 12-18
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Week 24-32
Secondary outcomes:
measure: Application Based - Timed Up and Go (TUG)
timeFrame: Week 0 to 4
measure: Application Based - Timed Up and Go (TUG)
timeFrame: Week 1-6
measure: Application Based - Timed Up and Go (TUG)
timeFrame: Week 12-18
measure: Application Based - Timed Up and Go (TUG)
timeFrame: Week 24-32
measure: Application Based - Tap Task
timeFrame: Week 0 to 4
measure: Application Based - Tap Task
timeFrame: Week 1-6
measure: Application Based - Tap Task
timeFrame: Week 12-18
measure: Application Based - Tap Task
timeFrame: Week 24-32
measure: Application Based - Path Test
timeFrame: Week 0 to 4
measure: Application Based - Path Test
timeFrame: Week 1-6
measure: Application Based - Path Test
timeFrame: Week 12-18
measure: Application Based - Path Test
timeFrame: Week 24-32
measure: Application Based - Transcription test
timeFrame: Week 0 to 4
measure: Application Based - Transcription test
timeFrame: Week 1-6
measure: Application Based - Transcription test
timeFrame: Week 12-18
measure: Application Based - Transcription test
timeFrame: Week 24-32
measure: Application Based - Timed 25-foot walk
timeFrame: Week 0 to 4
measure: Application Based - Timed 25-foot walk
timeFrame: Week 1-6
measure: Application Based - Timed 25-foot walk
timeFrame: Week 12-18
measure: Application Based - Timed 25-foot walk
timeFrame: Week 24-32
measure: Application Based - Coded Message Cognitive Test
timeFrame: Week 0 to 4
measure: Application Based - Coded Message Cognitive Test
timeFrame: Week 1-6
measure: Application Based - Coded Message Cognitive Test
timeFrame: Week 12-18
measure: Application Based - Coded Message Cognitive Test
timeFrame: Week 24-32
measure: Application Based - Six-minute walk test
timeFrame: Week 0 to 4
measure: Application Based - Six-minute walk test
timeFrame: Week 1-6
measure: Application Based - Six-minute walk test
timeFrame: Week 12-18
measure: Application Based - Six-minute walk test
timeFrame: Week 24-32
measure: Application Based - Contrast sensitivity test
timeFrame: Week 0 to 4
measure: Application Based - Contrast sensitivity test
timeFrame: Week 1-6
measure: Application Based - Contrast sensitivity test
timeFrame: Week 12-18
measure: Application Based - Contrast sensitivity test
timeFrame: Week 24-32
measure: Application Based - Arm elevation test
timeFrame: Week 0 to 4
measure: Application Based - Arm elevation test
timeFrame: Week 1-6
measure: Application Based - Arm elevation test
timeFrame: Week 12-18
measure: Application Based - Arm elevation test
timeFrame: Week 24-32
measure: Application Based - Memory test
timeFrame: Week 0 to 4
measure: Application Based - Memory test
timeFrame: Week 1-6
measure: Application Based - Memory test
timeFrame: Week 12-18
measure: Application Based - Memory test
timeFrame: Week 24-32
measure: Application Based - Vibration test
timeFrame: Week 0 to 4
measure: Application Based - Vibration test
timeFrame: Week 1-6
measure: Application Based - Vibration test
timeFrame: Week 12-18
measure: Application Based - Vibration test
timeFrame: Week 24-32
measure: Application Based - The Stroop Color and Word Test (SCWT)
timeFrame: Week 0 to 4
measure: Application Based - The Stroop Color and Word Test (SCWT)
timeFrame: Week 1-6
measure: Application Based - The Stroop Color and Word Test (SCWT)
timeFrame: Week 12-18
measure: Application Based - The Stroop Color and Word Test (SCWT)
timeFrame: Week 24-32
measure: Application Based - Self-reported mood, quality of life, function, and participation.
timeFrame: Week 0-4
measure: Application Based - Self-reported mood, quality of life, function, and participation.
timeFrame: Week 1-6
measure: Application Based - Self-reported mood, quality of life, function, and participation.
timeFrame: Week 12-18
measure: Application Based - Self-reported mood, quality of life, function, and participation.
timeFrame: Week 24-32
measure: Clinician Based - The Nine-Hole Peg Test (9HPT)
timeFrame: Week 0 to 4
measure: Clinician Based - The Nine-Hole Peg Test (9HPT)
timeFrame: Week 1-6
measure: Clinician Based - The Nine-Hole Peg Test (9HPT)
timeFrame: Week 12-18
measure: Clinician Based - The Nine-Hole Peg Test (9HPT)
timeFrame: Week 24-32
measure: Clinician Based - Red Saturation test
timeFrame: Week 0 to 4
measure: Clinician Based - Red Saturation test
timeFrame: Week 1-6
measure: Clinician Based - Red Saturation test
timeFrame: Week 12-18
measure: Clinician Based - Red Saturation test
timeFrame: Week 24-32
measure: Clinician Global Impression of Change (CGIC)
timeFrame: Week 0 to 4
measure: Clinician Global Impression of Change (CGIC)
timeFrame: Week 1-6
measure: Clinician Global Impression of Change (CGIC)
timeFrame: Week 12-18
measure: Clinician Global Impression of Change (CGIC)
timeFrame: Week 24-32
measure: Patient Global Impression of Change (PGIC )
timeFrame: Week 0 to 4
measure: Patient Global Impression of Change (PGIC )
timeFrame: Week 1-6
measure: Patient Global Impression of Change (PGIC )
timeFrame: Week 12-18
measure: Patient Global Impression of Change (PGIC )
timeFrame: Week 24-32
measure: Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL)
timeFrame: Week 0 to 4
measure: Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL)
timeFrame: Week 1-6
measure: Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL)
timeFrame: Week 12-18
measure: Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL)
timeFrame: Week 24-32
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Week 0 to 4
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Week 1-6
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Week 12-18
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Week 24-32
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laura Tabacof, MD
role: PRINCIPAL_INVESTIGATOR
References: