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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | 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. |
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| Sham | Sham Comparator | In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exopulse Mollii Suit | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in oxyhemoglobin level at baseline and at week 2. | 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. 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. |
| Changes in deoxyhemoglobin level at baseline and at week 2. | 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. 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. |
| Changes in tissue oxygenation index at baseline and at week 2. | 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. 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. |
| Change in total hemoglobin level at baseline and at week 2. | Total hemoglobin level is the sum of oxyhemoglobin and deoxyhemoglobin. It will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at baseline and at week 2. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Henri Mondor | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Exopulse Mollii suit (sham) | Device | In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. |
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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 week 4 and week 8. |
| Changes in oxyhemoglobin level at 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. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at week 4 and week 8. |
| Changes in deoxyhemoglobin level at 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. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at week 4 and week 8. |
| Changes in tissue oxygenation index at 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. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at week 4 and week 8. |
| Changes in total hemoglobin level at week 4 and week 8. | Total hemoglobin level is the sum of oxyhemoglobin and deoxyhemoglobin. It will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest. | This be assessed at week 4 and week 8. |
| Visual Analog Scale (VAS) pain | VAS ranges ranges from 0 (no pain) to 10 (the worst pain that the participant can imagine) | This be assessed at baseline, then at week 2, week 4 and week 8. |
| Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12) | Subjective changes in walking would be evaluated in patients who can walk by the Multiple Sclerosis Walking Scale - 12 (MSWS-12), a 12-item scale that examines the impact of MS on walking capacity, is a validated patient-reported measure for exploring this outcome. | This be assessed at week 4 and week 8. |
| Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale) | Subjective risk of fall will be assessed in patients who can walk using the French version of the Falls Efficacy Scale-International scale (FES-I) ; a 14-item scale that assesses the perceived risk of falling. | This be assessed at week 4 and week 8. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |