Exopulse Mollii Suit, Spasticity & Tissue Oxygenation (ENNOX)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Exopulse Mollii Suit; Device: Exopulse Mollii suit (sham)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • Hopital Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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; 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.
Sham Comparator: Sham; 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); In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

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 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.

Collaborators and Investigators

• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 22, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Spasticity; Oxygenation; Muscles
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Muscle Spasticity; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2021-A01665-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No