Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06780709

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-17

20

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (age 6518) with NMOSD diagnosed with 2015 NMOSD clinical criteria.
  • All EDSS scores are eligible to include patients regardless of disability.
  • Patients are eligible regardless of their current treatment type.
Not Eligible

You will not qualify if you...

  • Age less than 18 years.
  • Unable to voluntarily provide consent for study participation.
  • Unable to participate in study evaluations or endpoint measures.
  • Currently participating in another randomized controlled trial or wellness-based intervention.
  • Having a relapse within 30 days of randomization.
  • Having medical restrictions limiting physical activity.
  • Starting stimulants and/or dalfampridine between enrollment and randomization.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Corinne Goldsmith Dickinson Center for MS at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

S

Susan Filomena

CONTACT

S

Savannah Steer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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