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Wellness Program for Neuromyelitis Optica Spectrum Disorder (NMOSD)

This study is looking at whether a structured wellness program can improve the quality of life for people living with Neuromyelitis Optica Spectrum Disorder (NMOSD), a rare, lifelong autoimmune disease that damages the optic nerves and spinal cord. The program, called "Wellness Program and Behavioral Counseling," includes evaluations and support from dietitians, social workers, physical therapists, nurse practitioners, and behavioral neuropsychologists. You may be able to join if you are an adult (18 or older) with NMOSD, regardless of your disability level or current treatments. The study aims to see if participants' quality of life, measured by a specific questionnaire (MSQOL-54 Score), improves over time. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional pilot study that will randomly assign 20 participants to either start the wellness program immediately or after a 6-month delay.
What's involved
Participants will have initial evaluations, then complete assessments at baseline, 12 weeks, and 6 months. An optional extension study involves additional wellness interventions and bimonthly counseling for up to 18 months.
Compensation
Not stated in the trial record.
Follow-up
Participants in the core study will be followed for 6 months, with an option for an extension study that includes assessments at 12 and 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06780709

Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD

Recruiting
NAAges 18+InterventionalSupportive care
Icahn School of Medicine at Mount Sinai
~20 participants
Updated 2025-04-17 on ClinicalTrials.gov
What's tested:Wellness Program and Behavioral Counseling

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Multiple Sclerosis Quality of Life (MSQOL-54) Score
Measured over at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Explore related trials

Neuromyelitis Optica

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Sammita Satyanarayan, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Susan Filomena
[email protected]
212-241-3841
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults (age ≥18) with NMOSD diagnosed with 2015 NMOSD clinical criteria.
All EDSS scores will be considered in order to make the intervention accessible to all patients regardless of disability.
All patients regardless of treatment type will be considered.

Exclusion

Age\<18
Inability to voluntarily provide consent for study participation
Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention.
Any patients with a relapse within 30 days of randomization or any patients with medical restrictions on physical activity will be excluded.
Any patients who begin stimulants and/or dalfampridine between enrollment and randomization will be excluded.

What this trial measures

  • Multiple Sclerosis Quality of Life (MSQOL-54) Scoreat baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

    The MSQOL-54 is a 54-item comprehensive patient-reported questionnaire for individuals with MS. MSQOL-54 yields two main composite scores calculated using weighted averages of relevant areas: Physical Health Composite (PHC) - the physical function, health perceptions, energy/fatigue, role limitations- physical, pain, sexual function, social function, health distress scales. The Mental Health Composite (MHC) - the health distress, overall quality of life, emotional wellbeing, role limitations- emotional, cognitive function scales. Each composite scores range from 0-100, with total scale range from 0-100. Higher scores indicating better perceived health and quality of life. Lower scores suggest poorer quality of life impacted by MS. MSQOL-54 evaluates how MS affects various aspects of a patient's life and well-being, providing valuable insights into the patient's overall health status and the impact of MS on their daily functioning.