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Behavioural Intervention
NMOSDCopilot App for Neuromyelitis Optica (OPTIS Trial)
N/A
Recruiting
Research Sponsored by Ad scientiam
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1, month 2, month 3, month 4, month 5
Awards & highlights
OPTIS Trial Summary
This trial is designed to test a digital tool, called NMOSDCopilot, which allows patients to self-assess their symptoms of Neuromyelitis Optica Spectrum Disorder (NMOSD). The trial will compare the results of the digital tool to standard in-clinic testing, and will also evaluate the safety, usability, and satisfaction of the tool.
Who is the study for?
This trial is for adults aged 18-60 with Neuromyelitis Optica (NMO), specifically AQP4+ diagnosed by the 2015 criteria. Participants must be stable on treatment for at least 6 months, have an EDSS score of ≤7, and no relapses in the past 3 months. They need to own a compatible smartphone and understand the app's language.Check my eligibility
What is being tested?
The NMOSDCopilot smartphone application is being tested for its ability to accurately assess NMO symptoms at home compared to standard in-clinic tests. The study will also evaluate safety, usability, and satisfaction with both patient app and healthcare professional web portal.See study design
What are the potential side effects?
Since this trial involves a digital tool rather than medication or invasive procedures, traditional side effects are not expected. However, participants may experience frustration or fatigue from using the app if they find it difficult to navigate or use.
OPTIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1, month 2, month 3, month 4, month 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, month 2, month 3, month 4, month 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
Secondary outcome measures
To assess at-home compliance and adherence to the patient application
To assess bladder control
To assess bowel control
+11 moreOPTIS Trial Design
1Treatment groups
Experimental Treatment
Group I: NMOSDCopilotExperimental Treatment1 Intervention
Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
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Who is running the clinical trial?
Ad scientiamLead Sponsor
11 Previous Clinical Trials
1,649 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition has been stable for the last 3 months.I do not have major neurological, mental health issues, or severe injuries affecting my brain or limbs.I am under legal guardianship or curatorship.I am between 18 and 60 years old.My NMOSD treatment has been the same for the last 6 months, and my pain or mood medication hasn't changed in a month.My disability score is 7 or lower.I have been diagnosed with NMOSD and tested positive for AQP4 antibodies.I spend most of my day in bed or sitting, with less than 2 hours of activity.My NMOSD treatment has been the same for the last 6 months.My condition is diagnosed as NMOSD with AQP4 antibodies.I can walk with assistance.My condition has been stable with no relapse for the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: NMOSDCopilot
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over 45 years old being invited to become participants in this research?
"The parameters for inclusion in this medical study are persons between the age of 18 and 60. Furthermore, there is a separate trial available to those under 18 as well as one focused on patients over 65."
Answered by AI
Is enrollment still available for this research project?
"According to information found on clinicaltrials.gov, this medical trial is not presently recruiting patients. Initially posted in February 1st 2023 and last updated October 3rd 2022, the study has ceased its recruitment efforts; however, 24 other trials are currently open for enrolment."
Answered by AI
Who is authorized to join this medical trial?
"Prospective participants must meet the eligibility criteria of having neuromyelitis optica and residing in between 18-60 years old. This study is seeking 103 individuals in total."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
New York
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