Multiple SclerosisCOBRAMSNCT06280573
COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)
A study testing Wim Hoff method in people with Multiple Sclerosis, run by Comenius University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Wim Hoff method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Sep 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- relapse or corticosteroid treatment within 3 months prior to study enrollment
- severe/unstable comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Wim Hoff method
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wim Hoff methodCombination product
breathing exercises, cold exposure, and meditation
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Combination Product: Wim Hoff method |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of pro-inflammatory cytokines
blood concentrations in pg/ml of
- cytokines (interleukins - IL-1β, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-α2 and IFN-γ, tumor necrosis factor TNF-α, monocyte chemoattractant protein MCP-1)
Measured: 12 weeks
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),
Measured: 12 weeks
concentration of NfL
neurofilamen light chains
Measured: 12 weeks
concentration of GFAP
glial fibrillary acidic protein
Measured: 12 weeks
concentration of ecDNA
cell-free extracellular DNA
Measured: 12 weeks
Secondary outcomes (7)
Expanded Disability Status Scale
physical disability - score from 0.0 to 10.0
Measured: 12 weeks
Timed 25-Foot Walk
walking speed in seconds
Measured: 12 weeks
Nine-Hole Peg Test
finger dexterity in seconds
Measured: 12 weeks
Symbol Digit Modalities Test
cognitive status - score in 90s
Measured: 12 weeks
Fatigue Scale for Motor and Cognitive Functions
to assess multiple sclerosis-related fatigue
Measured: 12 weeks
General Anxiety Disorder-7
level of anxiety
Measured: 12 weeks
Patient Health Questionnaire-9
assesses degree of depression severity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Sep 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280573
- Sponsor's protocol ID
- MS1
- Acronym
- COBRAMS
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)
- ClinicalTrials.gov ID
- NCT06280573
- Acronym / sponsor ID
- COBRAMS / MS1
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Combination Product: Wim Hoff method |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- relapse or corticosteroid treatment within 3 months prior to study enrollment
- severe/unstable comorbidity
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 |
|---|---|---|
| Wim Hoff methodbreathing exercises, cold exposure, and meditation | Combination product | intervention group |
Primary outcome
concentration of pro-inflammatory cytokines
Time frame: 12 weeks
blood concentrations in pg/ml of • cytokines (interleukins - IL-1β, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-α2 and IFN-γ, tumor necrosis factor TNF-α, monocyte chemoattractant protein MCP-1)
concentration of markers of oxidative stress
Time frame: 12 weeks
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),
concentration of NfL
Time frame: 12 weeks
neurofilamen light chains
concentration of GFAP
Time frame: 12 weeks
glial fibrillary acidic protein
concentration of ecDNA
Time frame: 12 weeks
cell-free extracellular DNA
7 secondary outcomes
Expanded Disability Status Scale
Time frame: 12 weeks
Timed 25-Foot Walk
Time frame: 12 weeks
Nine-Hole Peg Test
Time frame: 12 weeks
Symbol Digit Modalities Test
Time frame: 12 weeks
Fatigue Scale for Motor and Cognitive Functions
Time frame: 12 weeks
General Anxiety Disorder-7
Time frame: 12 weeks
Patient Health Questionnaire-9
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wim Hoff method in people with Multiple Sclerosis, run by Comenius University at 1 site in Slovakia.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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 Slovakia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of pro-inflammatory cytokines (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 19 Mar 2024.