Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT05362006
• Lead Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study Start: 2022-03-01
• Study First Submitted QC: 2022-05-01
• Study First Posted: 2022-05-05
• Primary Completion: 2023-04-18
• Study Completion: 2023-05-30
• Status Verified: 2024-05
• Last Update Submitted: 2025-06-22
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in oxyhemoglobin level at baseline and at week 2.	This be assessed at baseline, then 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.
Changes in deoxyhemoglobin level at baseline and at week 2.	This be assessed at baseline, then 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.
Changes in tissue oxygenation index at baseline and at week 2.	This be assessed at baseline, then 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.
Change in total hemoglobin level at baseline and at week 2.	This be assessed 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.

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale (MAS)	This be assessed at baseline, then at week 2, week 4 and week 8.	MAS ranges from 0 (normal muscle tone ) to 4 (rigidity)
Numerical Rating Scale of spasticity (NRS)	This be assessed at baseline, then at week 2, week 4 and week 8.	NRS ranges ranges from 0 (no spasticity) to 10 (worse spasticity that the participant can imagine)
Changes in tissue oxygenation index at week 4 and week 8.	This be assessed 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.
Changes in total hemoglobin level at week 4 and week 8.	This be assessed 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.
Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)	This be assessed at week 4 and week 8.	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.
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)	This be assessed at week 4 and week 8.	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.
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)	This be assessed at week 4 and week 8.	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.
Changes in oxyhemoglobin level at week 4 and week 8.	This be assessed 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.
Changes in deoxyhemoglobin level at week 4 and week 8.	This be assessed 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.
Visual Analog Scale (VAS) pain	This be assessed at baseline, then at week 2, week 4 and week 8.	VAS ranges ranges from 0 (no pain) to 10 (the worst pain that the participant can imagine)

Trial Locations

Locations (1)

Hopital Henri Mondor; 🇫🇷 Créteil, France