Sensation, Motion, and Quality of Life on Natalizumab and Off Natalizumab

NCT05172466 | Withdrawn

• 1 other identifier: STUDY-20-02068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Keywords

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Mobile Applications; Natalizumab; Smartphone

Outcome Measures

Primary Outcomes (4)

• The Expanded Disability Status Scale (EDSS)

  The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability.

  Week 0 to 4

• The Expanded Disability Status Scale (EDSS)

  The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability.

  Week 1-6

• The Expanded Disability Status Scale (EDSS)

  The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability.

  Week 12-18

• The Expanded Disability Status Scale (EDSS)

  The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability.

  Week 24-32

Secondary Outcomes (76)

• Application Based - Timed Up and Go (TUG)

  Week 0 to 4

• Application Based - Timed Up and Go (TUG)

  Week 1-6

• Application Based - Timed Up and Go (TUG)

  Week 12-18

• Application Based - Timed Up and Go (TUG)

  Week 24-32

• Application Based - Tap Task

  Week 0 to 4

Study Arms (1)

BeCare application

EXPERIMENTAL

individuals with relapsing-remitting MS (RRMS) on Natalizumab therapy

Device: BeCare application

Interventions

BeCare application DEVICE

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.

BeCare application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Inability to perform 5 or more of the BeCare App tasks independently
• EDSS \>6.5
• Corrective Visual Acuity lower than 20/200
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Tabacof, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Instructor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 29, 2021
• Study Start: October 31, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)