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SOMAscan Diagnostic Test for Multiple Sclerosis (SPINCOMS Trial)

N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

SPINCOMS Trial Summary

This trial will test if a new medical test is able to accurately detect Multiple Sclerosis and other diseases of the central nervous system.

Who is the study for?
This trial is for individuals with Multiple Sclerosis (MS) who can attend in-person follow-ups and have had a lumbar puncture. They should be untreated at the time of the lumbar puncture, not on steroids for at least one month, and able to consent to future research use of their samples. Participants must also meet the 2017 McDonald criteria for MS diagnosis.Check my eligibility
What is being tested?
The study is using SOMAscan assay technology to analyze cerebrospinal fluid (CSF) samples from MS patients. It aims to find biomarkers that help detect differences between MS subtypes and other CNS diseases, as well as predict disease progression and treatment response.See study design
What are the potential side effects?
Since this trial involves CSF testing rather than drug intervention, typical medication side effects are not applicable. However, participants may experience discomfort or complications related to the lumbar puncture procedure.

SPINCOMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biomarker Predicted Outcomes against NeurEx-based outcomes
MS Severity Model Analyses

SPINCOMS Trial Design

4Treatment groups
Experimental Treatment
Group I: Relapsing Remitting Multiple SclerosisExperimental Treatment1 Intervention
Blood sample collection Vital signs, weight, height and BMI. Complete neurological examination documented in NeurEx (recorded with an iPAD). Clinical data questionnaire 25FW & non-dominant hand 9HPT (required for calculating CombiWISE & MS-DSS). Smartphone Apps (include 25FW, SDMT and tests that correlate highly w 9HPT - can be acquired in patient-autonomous manner with minimal assistance). Optical Coherence Tomography (OCT) CSF Analysis
Group II: Progressive Multiple SclerosisExperimental Treatment1 Intervention
Blood sample collection Vital signs, weight, height and BMI. Complete neurological examination documented in NeurEx (recorded with an iPAD). Clinical data questionnaire 25FW & non-dominant hand 9HPT (required for calculating CombiWISE & MS-DSS). Smartphone Apps (include 25FW, SDMT and tests that correlate highly w 9HPT - can be acquired in patient-autonomous manner with minimal assistance). Optical Coherence Tomography (OCT) CSF Analysis
Group III: Other Non-Inflammatory Neurological DiseasesExperimental Treatment1 Intervention
Clinical data questionnaire CSF Analysis
Group IV: Non-Inflammatory Neurological DiseasesExperimental Treatment1 Intervention
Clinical data questionnaire CSF Analysis

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,549 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
52,122 Patients Enrolled for Multiple Sclerosis
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,480,972 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
4,134 Patients Enrolled for Multiple Sclerosis
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,388 Total Patients Enrolled
20 Trials studying Multiple Sclerosis
2,607 Patients Enrolled for Multiple Sclerosis

Media Library

SOMAscan Clinical Trial Eligibility Overview. Trial Name: NCT04496830 — N/A
Multiple Sclerosis Research Study Groups: Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Non-Inflammatory Neurological Diseases, Other Non-Inflammatory Neurological Diseases
Multiple Sclerosis Clinical Trial 2023: SOMAscan Highlights & Side Effects. Trial Name: NCT04496830 — N/A
SOMAscan 2023 Treatment Timeline for Medical Study. Trial Name: NCT04496830 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are involved in this clinical experiment?

"Affirmative. The information provided on clinicaltrials.gov indicates that this research trial is still open to enrolling participants, which began being listed back in June 15th 2020 and was last updated on April 25th 2022. From 1 centre, 150 patients are sought for the study's progression."

Answered by AI

Are there still vacancies for volunteers to partake in this experiment?

"Affirmative. Per the information on clinicaltrials.gov, this medicinal research is presently searching for study participants. Initially posted on June 15th 2020, it was most recently amended April 25th 2022 and seeks 150 individuals at a single centre."

Answered by AI
Recent research and studies
~33 spots leftby Apr 2025