EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Scle
The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
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
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
To be assessed at baseline, week 2, week 4 and week 8
Spasticity
Other measures (12)
Numerical Rating Scale for spasticity.
This to be assessed at baseline, then at week 2, week 4 and week 8.
SpasticityMultiple 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)Visual Analog Score for pain.
This to be assessed at baseline, then at week 2, week 4 and week 8.
PainVisual Analog Score for fatigue.
This to be assessed at baseline, then at week 2, week 4 and week 8.
FatigueFall risk.
Two weeks after the second stimulation and at the end of phase 2.
Walking and mobilityWalking ability.
Two weeks after the second stimulation and at the end of phase 2.
Walking and mobilityOverall 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.
Weight
Baseline.
Height
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) \< 7.5). * Being free of relapses in the last three months. * Having spasticity with a score of at least 1+ on the MAS. * Female patients of child-bearing potential must agree to use adequate birth control measures * Voluntarily given, fully informed written and signed consent obtained before any study related procedures are conducted
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. * 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 muscular oxygenation in patients with Multiple Sclerosis and spasticity using Exopulse Molli suit stimulation. The main questions it aims to answer are: * to evaluate the short-term impact of EXOPULSE Molli suit on muscular oxygenation in adult MS patients suffering from spasticity. * to assess the effects of Exopulse Mollii suit on spasticity, pain, fatigue, quality of life (QoL), walking and risk of fall. Study subjects will participate in: * One baseline visit for inclusion in the study during which the patient will undergo the first session (active or sham) along with an evaluation before and after the session * One visit after two weeks during which the patient will undergo the second session (active or sham) along with an evaluation before and after the session * One visit two weeks after the second stimulation; where the patients will undergo a fifth evaluation and receive the EXOPULSE Molli Suit for the four-week open label phase to 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 sixth and last evaluation and return the EXOPULSE Molli suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of muscular oxygenation in patients with MS and spasticity using Exopulse Molli.
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
Andersen IT, Harrison A, Broholm R, Harder A, Nielsen JB, Bulow J, Pingel J. Microvascularization is not a limiting factor for exercise in adults with cerebral palsy. J Appl Physiol (1985). 2018 Aug 1;125(2):536-544. doi: 10.1152/japplphysiol.00827.2017. Epub 2018 May 3.Background
Aree-uea B, Auvichayapat N, Janyacharoen T, Siritaratiwat W, Amatachaya A, Prasertnoo J, Tunkamnerdthai O, Thinkhamrop B, Jensen MP, Auvichayapat P. Reduction of spasticity in cerebral palsy by anodal transcranial direct current stimulation. J Med Assoc Thai. 2014 Sep;97(9):954-62.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
Baumstarck-Barrau K, Pelletier J, Simeoni MC, Auquier P; MusiQol Study Group. [French validation of the Multiple Sclerosis International Quality of Life Questionnaire]. Rev Neurol (Paris). 2011 Jun-Jul;167(6-7):511-21. doi: 10.1016/j.neurol.2010.10.008. Epub 2011 Mar 21. French.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
Bethoux F. Spasticity Management After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):625-39. doi: 10.1016/j.pmr.2015.07.003. Epub 2015 Sep 26.
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History
Started
May 2023
Main results due
Mar 2024
Finished
Jul 2024