Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

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

CompletedNot a drug-phase studyMS (type not specified)NCT05362006

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Exopulse Mollii Suit

Placebo

  • Exopulse Mollii suit (sham)

What it measured

Main measures

  • Changes in oxyhemoglobin level at baseline and at week 2.

    This be assessed at baseline, then at week 2.

  • Changes in deoxyhemoglobin level at baseline and at week 2.

    This be assessed at baseline, then at week 2.

  • Changes in tissue oxygenation index at baseline and at week 2.

    This be assessed at baseline, then at week 2.

  • Change in total hemoglobin level at baseline and at week 2.

    This be assessed at baseline and at week 2.

Other measures (10)

  • Modified Ashworth Scale (MAS)

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

    Spasticity

  • Numerical Rating Scale of spasticity (NRS)

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

    Spasticity

  • Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)

    This be assessed at week 4 and week 8.

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • 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.

  • Changes in tissue oxygenation index at week 4 and week 8.

    This be assessed at week 4 and week 8.

  • Changes in total hemoglobin level at week 4 and week 8.

    This be assessed at week 4 and week 8.

  • Visual Analog Scale (VAS) pain

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

    Pain

  • Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)

    This be assessed at week 4 and week 8.

    Walking and mobilityQuality of life (reported by participants)

  • Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)

    This be assessed at week 4 and week 8.

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 75

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Mar 2022

    2. Main results due

      Apr 2023

    3. Finished

      May 2023

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