Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

Study Overview
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Brief Summary
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Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). Sustained contractile activity, such as that observed in spastic muscles, could reduce the capillary density and induce important changes in the muscular microcirculation, leading to oxidative changes within the muscular tissue. Such changes reflect altered aerobic metabolism and impaired mitochondrial function. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

Official Title
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The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Exopulse Mollii Suit
* Device: Exopulse Mollii suit (sham)


Participation Criteria
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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. Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale). Having spasticity with a score of at least 1+ on the MAS. 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 ( mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ) Prisoners.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. | Device: Exopulse Mollii Suit<br>* Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate 40 groups of muscles. This stimulation is not intended to obtain a motor effect (contraction of the muscles in question), but rather to decrease the spasticity in spastic muscles by activating the antagonistic muscles via the physiological mechanism of reciprocal inhibition. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more.<br>|
| Sham Comparator: Sham<br>In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. | Device: Exopulse Mollii suit (sham)<br>* In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline oxyhemoglobin level at week 2, week 4 and week 8. | Oxygemoglobin level will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. This is a wireless device - PortaMon (Artinis Medical Systems, The Netherlands) that consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at baseline, then at week 2, week 4 and week 8. | 
| Changes from baseline deoxyhemoglobin level at week 2, week 4 and week 8. | Deoxyhemoglobin level will be evaluated using the same Near Infrared Technology (NIRS) by means of a PortaMon device as previously described. The device can assess the level of deoxyhemoglobin of the muscle in question. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at baseline, then at week 2, week 4 and week 8. | 
| Changes from baseline tissue oxygenation index at week 2, week 4 and week 8. | Tissue oxygenation index will be evaluated using NIRS technology. A wireless device PortaMon (Artinis Medical Systems, The Netherlands)- is designed for this purpose, it consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation index. We will use two devices per patient. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at baseline, then at week 2, week 4 and week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale (MAS) | MAS ranges from 0 (normal muscle tone ) to 4 (rigidity) | This be assessed at baseline, then at week 2, week 4 and week 8. | 
| Numerical Rating Scale of spasticity (NRS) | NRS ranges ranges from 0 (no spasticity) to 10 (worse spasticity that the participant can imagine) | This be assessed at baseline, then at week 2, week 4 and week 8. | 
| Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) | Quality of life will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL). The MusiQoL questionnaire comprises 31 questions in 9 dimensions (subscales): activities of daily living (ADL, 8 items), psychological well-being (PWB, 4), symptoms (SPT, 4), relationships with friends (RFr, 3), relationships with family (RFa, 3), sentimental and sexual life (SSL, 2), coping (COP, 2), rejection (REJ, 2), and relationships with healthcare system (RHCS, 3). The index score is computed as the mean of these subscale scores. All 9 dimensions and the index score are linearly transformed and standardized on a 0 to 100 scale, where 0 indicates the worst possible level of QoL and 100 indicates the best level. | This be assessed at baseline, then at week 2, week 4 and week 8. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Oxygenation, Muscles, Spasticity