NMOSD
What it found
No result yet.
What was tested
Treatment tested
- Wellness Program and Behavioral Counseling
What it measured
Main measures
Multiple Sclerosis Quality of Life (MSQOL-54) Score
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Thinking and memoryFatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)
Other measures (4)
Impact of vision impairment (IVI) Score
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
VisionWalking and mobilityQuality of life (reported by participants)Neuro-Quality of Life (Neuro-QOL) Score
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Arm and hand functionQuality of life (reported by participants)The Godin Leisure Time and Exercise (GLTEQ) Score
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Physical functionQuality of life (reported by participants)Mediterranean Diet Compliance Scale (MEDAS)
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Who could take part
NMOSD · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Jan 2025
Main results due
Jan 2028
Finished
Jan 2028
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