Wellness Program for Neuromyelitis Optica Spectrum Disorder

(NMOSD Trial)

Overseen By Susan Filomena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Stimulants, Dalfampridine

Disqualifiers: Age <18, Recent relapse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 6 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients who start certain new medications like stimulants or dalfampridine after enrolling will be excluded.

What data supports the effectiveness of the treatment Wellness Program for Neuromyelitis Optica Spectrum Disorder?

Research on wellness programs for multiple sclerosis (MS), a condition similar to neuromyelitis optica spectrum disorder, shows that such programs can improve self-efficacy (belief in one's ability to manage their health), quality of life, and physical functioning. These programs often include education on health, stress management, and lifestyle changes, which have been beneficial for people with MS. ^{1 2 3 4 5}

Is the Wellness Program safe for humans?

The Wellness Program, initially developed for people with multiple sclerosis, showed improvements in various health areas without mentioning any safety concerns, suggesting it is generally safe for humans. ^{1 6 7 8 9}

How does the Wellness Program treatment for Neuromyelitis Optica Spectrum Disorder differ from other treatments?

The Wellness Program is unique because it focuses on a holistic approach, incorporating physical, mental, social, intellectual, and spiritual elements to improve self-efficacy (belief in one's ability to succeed), physical functioning, and symptom management, rather than relying solely on medication. ^{1 2 3 10 11}

What is the purpose of this trial?

This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists. The trial will be designed as a randomized controlled trial, randomizing patients to immediately starting the program as well as a 6 month delayed start. The intervention would leverage an existing clinical comprehensive MS wellness program at the Corinne Dickinson for Multiple Sclerosis (MS) at Mount Sinai Medical Center. The primary endpoint of this study would be evaluating quality of life, as assessed by MS-Quality of Life -54.

Research Team

Sammita Satyanarayan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD). Participants should be willing to engage in a wellness program that includes physical therapy, dietary advice, social support, nursing care, and cognitive therapy. The study excludes details on specific inclusion or exclusion criteria.

Inclusion Criteria

My level of disability will not exclude me from this study.

All patients regardless of treatment type will be considered

I am an adult diagnosed with NMOSD according to 2015 criteria.

Exclusion Criteria

I am unable to give my consent to participate in the study on my own.

Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a structured wellness program intervention tailored to NMOSD patients, including services from physical therapists, dietitians, social workers, nurse practitioners, and cognitive therapists.

6 months

Assessments at baseline, 12 weeks, and 6 months

Follow-up

Participants are monitored for sustainability of the wellness program, with assessments of quality of life, mobility, vision, exercise, and diet.

6 months

Assessments at 12 months and 18 months

Open-label extension (optional)

Participants may opt into a one-year extension study, receiving additional wellness interventions and bimonthly behavioral counseling sessions.

12 months

Treatment Details

Interventions

• Wellness Program

Trial Overview The trial tests a structured wellness program's impact on NMOSD patients' quality of life. It involves random assignment to either start the program immediately or after a six-month delay, using the MS-Quality of Life-54 as the primary measure of success.

Participant Groups

Group I: Immediate Start Experimental Treatment 1 Intervention

Participants will begin wellness program services and behavioral interventions immediately after randomization

Group II: Delayed Start Experimental Treatment 1 Intervention

Participants will experience a 6-month delay in receiving wellness program services and behavioral interventions.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

A wellness program for people with multiple sclerosis (MS) showed significant improvements in various health domains, including functional status, fatigue, and depression, based on data from 65 participants.

The program's focus on education and self-efficacy helped reduce fear-avoidance beliefs and pain, suggesting that a multidimensional approach can enhance overall well-being in MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a wellness program for people with multiple sclerosis: description and initial results. Hart, DL., Memoli, RI., Mason, B., et al.[2021]

A 4-day interdisciplinary wellness program for 129 individuals with multiple sclerosis (MS) led to significant improvements in self-efficacy and health-related quality of life (QOL) that were sustained for at least 6 months after the intervention.

The improvements in self-efficacy and QOL were consistent across participants regardless of their level of disability, indicating that the program is beneficial for all individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy and health status improve after a wellness program in persons with multiple sclerosis. Ng, A., Kennedy, P., Hutchinson, B., et al.[2015]

A wellness program designed for women with multiple sclerosis (MS) effectively promotes health by providing tailored knowledge and enhancing self-efficacy for health behaviors.

Participants in the two-phase intervention, which included knowledge-building classes and telephone follow-ups, reported positive changes in their health and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting wellness for women with multiple sclerosis. Stuifbergen, A., Becker, H., Rogers, S., et al.[2019]

The N-MOmentum trial is investigating the safety and efficacy of MEDI-551, an anti-CD19 monoclonal antibody, in patients with neuromyelitis optica spectrum disorder (NMOSD), with a focus on minimizing patient exposure to placebo over a treatment period of up to 197 days.

This trial employs innovative statistical methods and interim analyses to ensure robust results while addressing the unique challenges of NMOSD clinical trials, aiming to accurately assess treatment effects and reduce risks for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical Considerations for an Adaptive Design for a Serious Rare Disease. Patra, K., Cree, BAC., Katz, E., et al.[2020]

The Optimise:MS study has recruited over 2,000 participants from 14 hospitals in the UK to assess the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in real-world settings, focusing on serious adverse events (SAEs).

The study's statistical analysis plan is designed to address complex confounding factors and will provide valuable insights into the long-term outcomes of DMTs, including the effects of treatment switching and pregnancy outcomes, which are often not covered in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. Waddingham, E., Miller, A., Dobson, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Developing a wellness program for people with multiple sclerosis: description and initial results. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Self-efficacy and health status improve after a wellness program in persons with multiple sclerosis. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Promoting wellness for women with multiple sclerosis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of stress management for the prevention of new brain lesions in MS. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Health-related quality of life outcomes at 1 and 5 years after a residential retreat promoting lifestyle modification for people with multiple sclerosis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Statistical Considerations for an Adaptive Design for a Serious Rare Disease. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Response in Pediatric Neuromyelitis Optica Spectrum Disorder. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Factors Influencing Social Participation Among Persons With Neuromyelitis Optica Spectrum Disorders: A Cross-Sectional Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Exploring Wellness Interventions in Progressive Multiple Sclerosis: an Evidence-Based Review. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Mindfulness in Motion for People with Multiple Sclerosis: A Feasibility Study. [2020]