EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP)

Institut De La Colonne Vertebrale Et Des Neurosciences

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: EXOPULSE MOLLII SUIT (sham); Device: EXOPULSE MOLLII SUIT (active)

Study type: Interventional

Funder types: Other

Identifiers

NCT06702137

2022-A00231-42

Details and patient eligibility

About

Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). It can alter the patients' balance, mobility, as well as their quality of life. 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.

Full description

The investigators designed a randomized crossover, sham-controlled, double blind trial to demonstrate the improvement of motor functions and MS related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over four weeks (a session every other day for a total of 14 sessions) on MS related symptoms.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).
• 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.
• Having a BBS score ≤46 associated in the literature with a risk of fall

Exclusion criteria

• Being included in another research protocol during the study period.
• Inability to undergo medical monitoring 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Experimental Condition

Active Comparator group

Description:

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. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted. EXOPULSE Mollii Suit is used for the activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax.

Treatment:

Device: EXOPULSE MOLLII SUIT (active)

Control Condition

Sham Comparator group

Description:

In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour).

Treatment:

Device: EXOPULSE MOLLII SUIT (sham)