EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)
NCT ID: NCT05912595
Last Updated: 2024-01-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-05-18
Study Completion Date
2024-07-01
Brief Summary
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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.
* 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.
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Detailed Description
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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.
Conditions
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Sclerosis, Multiple
MS (Multiple Sclerosis)
Spastic
Spasticity, Muscle
Oxygen Consumption
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
EXOPULSE Mollii Suit Stimulation
Intervention Type
DEVICE
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.
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.
Group Type
SHAM_COMPARATOR
EXOPULSE Mollii Suit Stimulation
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sheikh Shakhbout Medical City
OTHER
Sponsor Role
lead
Responsible Party
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Naji Joseph Riachi
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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SSMC
Abu Dhabi, , United Arab Emirates
Site Status
RECRUITING
Countries
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United Arab Emirates
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ENNOX2
Identifier Type: -
Identifier Source: org_study_id
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