Dent Neurologic Institute
Amherst, New York, 14226, United States
NCT Number: NCT06282081
This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Amherst, New York, 14226, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The purpose of this research is to investigate a biomarker, called serum neurofilament light (sNfL), which is measured in blood. This study will attempt to investigate whether or not sNfL is a useful tool for clinicians in patients diagnosed with relapsing remitting multiple sclerosis.
Time frame: 1 year
This outcome is based on structured clinician questionnaires developed for this study. Prior to receiving patient sNfL results, clinicians will answer the question "My current clinical impression of this patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)." After receiving patient sNfL results, clinicians will answer the question "After reviewing this patient's sNfL results along with other diagnostic testing at this time, my opinion of the patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)" and these answers will be reported.
Time frame: 1 year
This outcome is based on a structured clinician questionnaire developed for this study. Clinicians will answer the question: "This patient's sNfL results have had the following impact on my opinions or confidence in this patient's care plan, or have potential to guide my clinical practice in the following way (please list specifics, e.g., increased confidence in assessment of disease status; decision to order additional testing; change in mediation therapy; change in frequency of follow-up, etc)" and these answers will be reported.
Time frame: 1 year
Time frame: 1 year
This outcome is based on a structured clinician questionnaire developed for this study. Prior to receiving patient's sNfL results, clinicians will answer the question, "Is this an unscheduled sNfL measurement? Yes No; If yes, please specify reason why this sNfL measurement was scheduled" and these answers will be reported.
Time frame: 1 year
After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "Knowledge of sNfL level has the potential to be useful in my clinical practice for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely."
Time frame: 1 year
After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "sNfL results has the potential to be a useful/suitable alternative to MRI for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely."
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Severity of MS relapses will be described by change in EDSS score from non-relapsing EDSS measurement.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more accessible: ____________ " and these answers will be reported.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more burdensome: ___________" and these answers will be reported.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more uncomfortable: ___________" and these answers will be reported.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were easier to fit into my schedule: ____________" and these answers will be reported.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL results were more difficult to understand: ____________" and these answers will be reported.
Time frame: 1 year
This outcome is based on structured patient questionnaires developed for this study. Patients will answer the following question before and after receiving sNfL results: "My current understanding of my MS disease is that I am (circle one): a. Stable, b. Experiencing increased disease activity, c. At risk for relapse, d. Experiencing a relapse, e. Unknown" and these answers will be reported.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? sNfL results were easy to understand: _______" and these results will be reported.
Time frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? sNfL results increased my knowledge of my MS disease status: ____________" and these results will be reported.
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS.
Time frame: 1 year
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
Time frame: 1 year
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
Time frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Time frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS.
Time frame: 1 year
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
Time frame: 1 year
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
Time frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Time frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
Time frame: 1 year
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
Time frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Time frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Time frame: 1 year
Time frame: 1 year
Dent Neuroscience Research Center
Other
Serum Neurofilament Light As a Clinical Tool in Relapsing Remitting Multiple Sclerosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04289909
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Paris, France
View Trial DetailsNCT04858763
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Nottingham, United Kingdom
View Trial DetailsNCT04201470
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Montpellier, France
View Trial DetailsNCT06887426
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Strasbourg, France
View Trial Details