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EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)

Study Purpose

The goal of this clinical trial is to demonstrate the improvement of muscular oxygenation in patients with Multiple Sclerosis and spasticity using Exopulse Molli suit stimulation. The main questions it aims to answer are:

- to evaluate the short-term impact of EXOPULSE Molli suit on muscular oxygenation in adult MS patients suffering from spasticity.

- to assess the effects of Exopulse Mollii suit on spasticity, pain, fatigue, quality of life (QoL), walking and risk of fall.

Study subjects will participate in:

- One baseline visit for inclusion in the study during which the patient will undergo the first session (active or sham) along with an evaluation before and after the session.

- One visit after two weeks during which the patient will undergo the second session (active or sham) along with an evaluation before and after the session.

- One visit two weeks after the second stimulation; where the patients will undergo a fifth evaluation and receive the EXOPULSE Molli Suit for the four-week open label phase to use the suit at home for an active stimulation session every other day for four weeks.

- One visit at the end of the open label phase to perform the sixth and last evaluation and return the EXOPULSE Molli suit.

Researchers will compare both Active and Sham groups to demonstrate the improvement of muscular oxygenation in patients with MS and spasticity using Exopulse Molli.

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 - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.

- Age between 18 and 75 years.

- Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) < 7.5).

- Being free of relapses in the last three months.

- Having spasticity with a score of at least 1+ on the MAS.

- Female patients of child-bearing potential must agree to use adequate birth control measures.

- Voluntarily given, fully informed written and signed consent obtained before any study related procedures are conducted.

Exclusion Criteria:

- Being included in another research protocol during the study period.

- Inability to undergo medical monitor for the study purposes due to geographical or social reasons.

- Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using Exopulse Mollii suit.

- Being pregnant.

- Having a change in their pharmacological therapy in the last three months.

- Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).

- Having a body mass index above 35 Kg/m2.

- In case of the introduction of a medical device other than Exopulse Mollii suit during the study period.

- Patients under juridical protection.

- Prisoners.

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.	NCT05912595
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.	Sheikh Shakhbout Medical City
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Arab Emirates
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic, Spasticity, Muscle, Oxygen Consumption

Additional Details

The study is a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of tissue oxygenation and frequent MS symptoms following a single session of "active" versus "sham" Exopulse Mollii suit separated by 2 weeks. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for one month (3 sessions per week) on tissue oxygenation and MS related symptoms.

Arms & Interventions

Arms

Active Comparator: EXOPULSE Mollii Suit Stimulation Active.

This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.

Sham Comparator: EXOPULSE Mollii Suit Stimulation Sham.

This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes.

Interventions

Device: - EXOPULSE Mollii Suit Stimulation

We designed a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of tissue oxygenation and frequent MS symptoms following a single session of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for one month (3 sessions per week) on tissue oxygenation and MS related symptoms.

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

SSMC, Abu Dhabi, United Arab Emirates

Status

Recruiting

Address

SSMC

Abu Dhabi, ,

Site Contact

Naji J Riachi, MD

[email protected]

+971 2 314 4444 #2979

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