Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

NCT05362006 | Completed

• 1 other identifier: 2021-A01665-36
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Oxygenation; Muscles; Spasticity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Modified Ashworth Scale (MAS)

  This be assessed at baseline, then at week 2, week 4 and week 8.

• Numerical Rating Scale of spasticity (NRS)

  This be assessed at baseline, then at week 2, week 4 and week 8.

• Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)

  This be assessed at week 4 and week 8.

• Changes in oxyhemoglobin level at week 4 and week 8.

  This be assessed at week 4 and week 8.

• Changes in deoxyhemoglobin level at week 4 and week 8.

  This be assessed at week 4 and week 8.

Study Arms (2)

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.

Device: Exopulse Mollii Suit

Sham

SHAM COMPARATOR

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)

Interventions

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.

Active

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.

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (1)

Hopital Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: May 5, 2022
• Study Start: March 1, 2022
• Primary Completion: April 18, 2023
• Study Completion: May 30, 2023
• Last Updated: June 26, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)