Wellness program to improve quality of life in NMOSD patients
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
This study is testing a wellness program to see if it can improve the quality of life for people with Neuromyelitis Optica Spectrum Disorder (NMOSD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06780709 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness of a structured wellness program designed to enhance the quality of life for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD). The pilot study will involve 20 participants who will be randomly assigned to either an immediate intervention group or a control group that starts the program after six months. The wellness intervention includes services from physical therapists, dietitians, social workers, and cognitive therapists, with assessments conducted at baseline, 12 weeks, and 6 months to evaluate outcomes. The primary focus is on measuring quality of life using the MS-Quality of Life -54 scale.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with NMOSD who can participate in the study evaluations.
Not a fit: Patients under 18, those unable to provide consent, or those with recent relapses or medical restrictions on physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life for patients living with NMOSD.
How similar studies have performed: While similar wellness interventions have shown promise in other conditions, this specific approach for NMOSD is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: * 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.
Where this trial is running
New York, New York
- Corinne Goldsmith Dickinson Center for MS at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sammita Satyanarayan, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Susan Filomena
- Email: susan.filomena@mssm.edu
- Phone: 212-241-3841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.