Clinical trial NCT05362006: Exopulse Mollii Suit, Spasticity & Tissue Oxygenation
Official title: The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Oxygenation
Muscles
Spasticity
Lead sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Changes from baseline oxyhemoglobin level at week 2, week 4 and week 8.
timeFrame: This be assessed at baseline, then at week 2, week 4 and week 8.
measure: Changes from baseline deoxyhemoglobin level at week 2, week 4 and week 8.
timeFrame: This be assessed at baseline, then at week 2, week 4 and week 8.
measure: Changes from baseline tissue oxygenation index at week 2, week 4 and week 8.
timeFrame: This be assessed at baseline, then at week 2, week 4 and week 8.
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: This be assessed at baseline, then at week 2, week 4 and week 8.
measure: Numerical Rating Scale of spasticity (NRS)
timeFrame: This be assessed at baseline, then at week 2, week 4 and week 8.
measure: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
timeFrame: This be assessed at baseline, then at week 2, week 4 and week 8.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hopital Henri Mondor
Study officials:
References: