Recruiting

Wellness Behavioral Intervention

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06780709

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wellness Program and Behavioral Counseling

Study Details

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.

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Study ID

NCT06780709

Start date

Jan 21, 2025

Status verified date

Apr, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Immediate Start

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

other: Delayed Start

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

Interventions

Wellness Program and Behavioral Counseling

The comprehensive wellness evaluation will include initial assessments by dietician, social worker, physical therapist, nurse practitioner, and a behavioral neuropsychologist. Each provider will conduct an initial evaluation at baseline to identify areas of need and patient driven goals, as well as follow-up evaluations to evaluate implementation of changes and barriers to change.

Primary outcome measure

  • Multiple Sclerosis Quality of Life (MSQOL-54) Score [ Time Frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study ]

Central Contacts and Locations

Central contacts

Susan Filomena

212-241-3841susan.filomena@mssm.edu

Savannah Steer

212-241-4264savannah.steer@mssm.edu

Locations

Corinne Goldsmith Dickinson Center for MS at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Sammita Satyanarayan

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 17, 2025

Last verified

Apr, 2025

Keywords

  • NMOSD
  • Wellness
  • Diet
  • Physical Therapy
  • Social Work
  • Comprehensive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-04-17.