NCT06780709 Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
| NCT ID | NCT06780709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Neuromyelitis Optica Spectrum Disorder (NMOSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-01-28 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Sammita Satyanarayan, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06780709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuromyelitis Optica Spectrum Disorder (NMOSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780709 currently recruiting?
Yes, NCT06780709 is actively recruiting participants. Contact the research team at susan.filomena@mssm.edu for enrollment information.
Where is the NCT06780709 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06780709 clinical trial?
NCT06780709 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Sammita Satyanarayan, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 20 participants.