EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)
The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- EXOPULSE Mollii Suit Stimulation
What it measured
Main measures
Balance using Berg Balance Scale (BBS)
To be assessed at baseline.
Walking and mobilityBalance using Berg Balance Scale (BBS)
To be assessed at week 2.
Walking and mobilityBalance using Berg Balance Scale (BBS)
To be assessed at week 4.
Walking and mobilityBalance using Berg Balance Scale (BBS)
To be assessed at week 8.
Walking and mobility
Other measures (13)
Visual Analog Score for spasticity.
This to be assessed at baseline, then at week 2, week 4 and week 8.
SpasticityMobility.
Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Walking and mobilityVisual Analog Score for pain.
This to be assessed at baseline, then at week 2, week 4 and week 8.
PainMultiple Sclerosis International Quality of Life Questionnaire.
Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Bladder, bowel and sexual functionQuality of life (reported by participants)Overall Clinical improvement.
This to be assessed at baseline, then at week 2, and week 8.
Blinding Questionnaire.
This to be assessed at baseline, then at week 2.
Visual Analog Score for fatigue.
This to be assessed at baseline, then at week 2, week 4 and week 8.
FatigueMuscle tone.
This to be assessed at baseline, then at week 2, week 4 and week 8.
SpasticityFall Risk
Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Walking and mobilityWeight.
Baseline
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). * Being free of relapses in the last three months. * Being able to understand verbal instructions. * 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 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/m\^2. * In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period. * Patients under juridical protection. * Prisoners.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. The main questions it aims to answer are: * to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult MS patients suffering from spasticity. * to assess the effects of EXOPULSE Mollii suit on mobility, upper and lower limbs muscle tone, pain, fatigue and quality of life. Participants will participate in: * One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session) * One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session) * One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will use the suit at home for an active stimulation session every other day for four weeks. * One visit at the end of the open label phase to perform the fourth and last evaluation and return the EXOPULSE Mollii suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit.
Papers
Background
Andringa A, van de Port I, van Wegen E, Ket J, Meskers C, Kwakkel G. Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2019 Sep;100(9):1703-1725. doi: 10.1016/j.apmr.2019.01.016. Epub 2019 Feb 21.Background
Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013 Dec;123(12):850-8. doi: 10.3109/00207454.2013.812084. Epub 2013 Jul 15.Background
Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.Background
Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.Background
Baude M, Nielsen JB, Gracies JM. The neurophysiology of deforming spastic paresis: A revised taxonomy. Ann Phys Rehabil Med. 2019 Nov;62(6):426-430. doi: 10.1016/j.rehab.2018.10.004. Epub 2018 Nov 28.Background
Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess. 2003;7(40):iii, ix-x, 1-111. doi: 10.3310/hta7400.Background
Bennett SE, Bromley LE, Fisher NM, Tomita MR, Niewczyk P. Validity and Reliability of Four Clinical Gait Measures in Patients with Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):247-252. doi: 10.7224/1537-2073.2015-006.Background
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.Background
Burke D, Wissel J, Donnan GA. Pathophysiology of spasticity in stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S20-6. doi: 10.1212/WNL.0b013e31827624a7.Background
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
Loading reviews and guidelines…
History
Started
Mar 2023
Main results due
Dec 2024
Finished
Apr 2025