Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

Study Purpose

the aim of the study is to evaluate the effectiveness of partial-body cryotherapy (PBC) on the symptoms of patients with multiple sclerosis during a rehabilitation stay.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- men and woen over 18 years old and under 65 years old.

- with multiple sclerosis.

- 0-6 points in the expanded disability states scale (EDSS) - with MS in remission (at least 6 months since the last relapse) - able to understand and respect the protocol and its requirement.

- who signed the consent prior to any other procedure protocol.

Exclusion Criteria:

- major patients under guardianship/curators/legal protection.

- pregnant patients.

- patients with contraindication for cryotherapy.

- patients unable to complete the entire program.

- patients with substantial change in pharmacological treatment the month before the start of the study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05219201
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondation Ildys
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jean-Baptiste Bourseul, MD
Principal Investigator Affiliation	Fondation Ildys
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Additional Details

Multiple sclerosis (MS) is a chronic heterogeneous disease with an unpredictable clinical course. Symptoms can include paralysis, ataxia, spasticity, incontinence and fatigue syndrome. Fatigue is considered to be the most prevalent and disabling of the symptoms at all stages of the illness and its occurs in 70-80% of patients. This characteristic of the disease directly impacts the quality of life of patients, affecting their social and physical well being. Physical rehabilitation is often prescribed in the management of MS, and is recognized to improve modifiable impairments in MS. However, the benefit of physical activities may be limited by heat stress also named Uhthoff syndrome frequently observed in patients with MS. Cryotherapy is commonly used as a method to relieve pain and inflammation without marked side effect in respect to contraindication. However well designed studies on PBC in patients with MS are still too sparse. The investigators propose to evaluate the effectiveness of PBC on the symptoms of MS patients during a rehabilitation stay in out- or inpatients.

Arms & Interventions

Arms

Sham Comparator: Sham cryotherapy full time patient (inpatient)

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay

Sham Comparator: sham cryotherapy part-time hospitalized patient (outpatient)

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay

Active Comparator: cryotherapy full-time hospitalized patient (inpatient)

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay

Active Comparator: cryotherapy part-time hospitalized patient (outpatient)

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay

Interventions

Device: - partial-body cryotherapy chamber session

The cryotherapy procedure consisted of a 2-3 min stay in the cryotherapy chamber: at -30°C for sham cryotherapy session at -120°C for cryotherapy intervention session. For Inpatients, cryotherapy session will be performed daily, late in the afternoon, excluding saturdays and sundays, during 3 weeks. (15 sessions) For outpatient, cryotherapy session will occured late in the afternoon each day care (15 sessions).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre de Perharidy, Roscoff, France

Status

Recruiting

Address

Centre de Perharidy

Roscoff, ,

Site Contact

Jocelyne PENGAM

[email protected]

02.98.02.85.00

Clinical Trials in MS

The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Clinical Trial Finder