Neuromyelitis Optica Spectrum Disorder (NMOSD)NMOSDNCT06780709
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
A study testing Wellness Program and Behavioral Counseling in people with Neuromyelitis Optica Spectrum Disorder (NMOSD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
- What is being tested?
- Wellness Program and Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corinne Goldsmith Dickinson Center for MS at Mount Sinai
New York, New York, 10029
Sammita Satyanarayan
Ilana Katz-Sand, MD
About this study
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.
Read the detailed description
This pilot will aim to recruit 20 patients. Participants will be randomized into one of two arms: the trial group will begin wellness program services and behavioral interventions immediately; the control group will participate in other educational activities, and begin wellness program services and behavioral interventions 6 months after randomization. The wellness intervention will include dietary, physical therapy, social work, and nurse practitioner evaluations, as well as behavioral counseling to implement recommendations. All participants will complete assessments, with patient-reported outcome surveys and objective assessments at baseline, 12 weeks, and 6 months for the core study. Participants will also be offered the option of continuing into a one year extension study, wherein one additional wellness intervention and bimonthly behavioral counseling sessions will be offered until 12 months on study. Study assessments will be completed at 12 months and 18 months to assess sustainability of the program. Assessments will include subjective reports of quality of life as pertaining to living with their disease, mobility, vision, exercise, diet, as well as objective measures of motor and vision function.
- Being tested
- Wellness Program and Behavioral Counseling
- Keywords
- NMOSD, Wellness, Diet, Physical Therapy, Social Work, Comprehensive
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Program and Behavioral CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Start | Experimental | Participants will begin wellness program services and behavioral interventions immediately after randomization Receives: Behavioral: Wellness Program and Behavioral Counseling |
| Delayed Start | Other | Participants will experience a 6-month delay in receiving wellness program services and behavioral interventions. Receives: Behavioral: Wellness Program and Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Quality of Life (MSQOL-54) Score
The MSQOL-54 is a 54-item comprehensive patient-reported questionnaire for individuals with MS.
MSQOL-54 yields two main composite scores calculated using weighted averages of relevant areas: Physical Health Composite (PHC) - the physical function, health perceptions, energy/fatigue, role limitations- physical, pain, sexual function, social function, health distress scales. The Mental Health Composite (MHC) - the health distress, overall quality of life, emotional wellbeing, role limitations- emotional, cognitive function scales.
Each composite scores range from 0-100, with total scale range from 0-100. Higher scores indicating better perceived health and quality of life. Lower scores suggest poorer quality of life impacted by MS. MSQOL-54 evaluates how MS affects various aspects of a patient's life and well-being, providing valuable insights into the patient's overall health status and the impact of MS on their daily functioning.
Measured: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Secondary outcomes (4)
Impact of vision impairment (IVI) Score
The Impact of Vision Impairment (IVI) is a 32-item patient-reported instrument measuring vision impairment's effect on quality of life and daily activities. The questionnaire assesses five domain subscales: Leisure and Work, Social and Consumer Interaction, Household and Personal Care, Mobility, and Emotional Reaction to Vision Loss. Items use a 6-point Likert scale (0: Not at all, 1: Hardly at all, 2: A little, 3: A fair amount, 4: A lot, 5: Can't do because of eyesight). Domain subscale scores are calculated as the mean of items within each domain, and the total score is the mean of all items. Subscales range from 0-5, with total scale range from 0-5. Lower scores indicating better vision-related quality of life. A decrease in scores represents improvement over time.
Measured: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Neuro-Quality of Life (Neuro-QOL) Score
Neuro QOL (quality of life) subscales indicating upper extremity function, lower extremity function, executive function, ability to participate in social roles/activities, satisfaction with social roles and activities) will be assessed. Scores are assessed and compared to normative data, with a T score generated. T distributions assume a mean of 50, and the standard deviation is set to 10 units. A higher T score value indicates a greater deviation from normal functioning.
Measured: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
The Godin Leisure Time and Exercise (GLTEQ) Score
The GLTEQ is a patient reported scale assessing patient reported frequency of exercise in a typical 7-day period during their free time. Total Scale is weighted to calculate a composite score from 0-99, with a higher score indicating a more active lifestyle.
Measured: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Mediterranean Diet Compliance Scale (MEDAS)
MEDAS questionnaire is a self-reported recall of food consumption. This is a 14-item questionnaire, with each item being scored as a 0 or 1 indicating consumption of the specified category of food, with a total scale range of 0-14. A higher score indicates a higher alignment with a mediterranean based diet.
Measured: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start21 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorder (NMOSD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two assigned arms of the trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sammita Satyanarayan, Icahn School of Medicine at Mount Sinai
- Investigators
- Sammita Satyanarayan, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780709
- Sponsor's protocol ID
- STUDY-23-01257
- Other IDs
- ISRA# 370464
- Acronym
- NMOSD
- Status last verified
- Apr 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dataset includes sensitive data such as substance use (from dietary surveys) and mental health status.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
- ClinicalTrials.gov ID
- NCT06780709
- Acronym / sponsor ID
- NMOSD / STUDY-23-01257
- Keywords
- NMOSD, Wellness, Diet, Physical Therapy, Social Work, Comprehensive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot will aim to recruit 20 patients. Participants will be randomized into one of two arms: the trial group will begin wellness program services and behavioral interventions immediately; the control group will participate in other educational activities, and begin wellness program services and behavioral interventions 6 months after randomization. The wellness intervention will include dietary, physical therapy, social work, and nurse practitioner evaluations, as well as behavioral counseling to implement recommendations. All participants will complete assessments, with patient-reported outcome surveys and objective assessments at baseline, 12 weeks, and 6 months for the core study. Participants will also be offered the option of continuing into a one year extension study, wherein one additional wellness intervention and bimonthly behavioral counseling sessions will be offered until 12 months on study. Study assessments will be completed at 12 months and 18 months to assess sustainability of the program. Assessments will include subjective reports of quality of life as pertaining to living with their disease, mobility, vision, exercise, diet, as well as objective measures of motor and vision function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into two assigned arms of the trial.
| Arm | Type | Receives |
|---|---|---|
| Immediate Start | Experimental | Behavioral: Wellness Program and Behavioral CounselingParticipants will begin wellness program services and behavioral interventions immediately after randomization |
| Delayed Start | Other | Behavioral: Wellness Program and Behavioral CounselingParticipants will experience a 6-month delay in receiving wellness program services and behavioral interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Program and Behavioral CounselingThe 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. | Behavioural | Delayed Start, Immediate Start |
Primary outcome
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
The MSQOL-54 is a 54-item comprehensive patient-reported questionnaire for individuals with MS. MSQOL-54 yields two main composite scores calculated using weighted averages of relevant areas: Physical Health Composite (PHC) - the physical function, health perceptions, energy/fatigue, role limitations- physical, pain, sexual function, social function, health distress scales. The Mental Health Composite (MHC) - the health distress, overall quality of life, emotional wellbeing, role limitations- emotional, cognitive function scales. Each composite scores range from 0-100, with total scale range from 0-100. Higher scores indicating better perceived health and quality of life. Lower scores suggest poorer quality of life impacted by MS. MSQOL-54 evaluates how MS affects various aspects of a patient's life and well-being, providing valuable insights into the patient's overall health status and the impact of MS on their daily functioning.
4 secondary outcomes
Impact of vision impairment (IVI) Score
Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Neuro-Quality of Life (Neuro-QOL) Score
Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
The Godin Leisure Time and Exercise (GLTEQ) Score
Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Mediterranean Diet Compliance Scale (MEDAS)
Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. Dataset includes sensitive data such as substance use (from dietary surveys) and mental health status.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sammita Satyanarayan, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Program and Behavioral Counseling in people with Neuromyelitis Optica Spectrum Disorder (NMOSD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Filomena (212-241-3841, susan.filomena@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.