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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06280573
Other study ID # MS1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source Comenius University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis. Researchers will compare the effect to control groups of MS patients without intervention.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - RRMS diagnosed according to the official 2020 McDonald's criteria, - age 18-55 years, - MS duration up to 10 years, - EDSS 1.0-5.5, - willingness to participate Exclusion Criteria: - relapse or corticosteroid treatment within 3 months prior to study enrollment - severe/unstable comorbidity

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Wim Hoff method
breathing exercises, cold exposure, and meditation

Locations

Country Name City State
Slovakia Derer's University Hospital Bratislava

Sponsors (1)

Lead Sponsor Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary concentration of pro-inflammatory cytokines blood concentrations in pg/ml of
• cytokines (interleukins - IL-1ß, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-a2 and IFN-?, tumor necrosis factor TNF-a, monocyte chemoattractant protein MCP-1)
12 weeks
Primary concentration of markers of oxidative stress blood concentration in mmol/l of markers of oxidative stress (OS) - advanced glycation end products (AGEs), fructosamine, advanced oxidation protein products (AOPP), thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (TAC), ferric reducing ability of plasma (FRAP), 12 weeks
Primary concentration of NfL neurofilamen light chains 12 weeks
Primary concentration of GFAP glial fibrillary acidic protein 12 weeks
Primary concentration of ecDNA cell-free extracellular DNA 12 weeks
Secondary Expanded Disability Status Scale physical disability - score from 0.0 to 10.0 12 weeks
Secondary Timed 25-Foot Walk walking speed in seconds 12 weeks
Secondary Nine-Hole Peg Test finger dexterity in seconds 12 weeks
Secondary Symbol Digit Modalities Test cognitive status - score in 90s 12 weeks
Secondary Fatigue Scale for Motor and Cognitive Functions to assess multiple sclerosis-related fatigue 12 weeks
Secondary General Anxiety Disorder-7 level of anxiety 12 weeks
Secondary Patient Health Questionnaire-9 assesses degree of depression severity 12 weeks
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