At Home Use of Stimulation Suits for Managing MS Symptoms
NCT ID: NCT07202195
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2026-03-31
2027-09-30
Brief Summary
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Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?
Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).
Participants in the intervention group will:
* Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home).
* Receive their usual care in addition to wearing the suit.
* Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.
Participants in the control group will:
* Receive their usual care.
* Undergo clincial tests at the same time points as the other group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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stimulation suit group
This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care.
electro-stimulation suit
In EXOPULSE Mollii Suit is a multi-channel full-body suit with a low energy electrical stimulation - 20 Volt and 20 Hz. It generates 2 milliamp pulses (into 0-10,000 Ohms) with the following parameters:
* Pulse width: variable between 25 and 170 μs.
* Length of period: 50 ms.
* Maximum amplitude: 20 V. It is composed of a control unit, a jacket and pants, with 58 embed-ded electrodes, in direct contact with the skin, and pre-positioned to stimulate 40 key muscle groups.
The suit comes in different sizes. A trained medical staff pre-programs which nerves/muscles to be stimulated based on a clinical assessment of the user and the outcome is evaluated through standardized methods. The stimulation program is thus specific to each user.
Usual Care
The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced/adjusted to make time for initiation and follow-up of using the neuromodulation suit and potentially also during the weeks at home (i.e., rehabilitation being offered by municipalities).
usual care
This group will be a comparator and have no added intervention expect for their usual care.
Usual Care
The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced/adjusted to make time for initiation and follow-up of using the neuromodulation suit and potentially also during the weeks at home (i.e., rehabilitation being offered by municipalities).
Interventions
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electro-stimulation suit
In EXOPULSE Mollii Suit is a multi-channel full-body suit with a low energy electrical stimulation - 20 Volt and 20 Hz. It generates 2 milliamp pulses (into 0-10,000 Ohms) with the following parameters:
* Pulse width: variable between 25 and 170 μs.
* Length of period: 50 ms.
* Maximum amplitude: 20 V. It is composed of a control unit, a jacket and pants, with 58 embed-ded electrodes, in direct contact with the skin, and pre-positioned to stimulate 40 key muscle groups.
The suit comes in different sizes. A trained medical staff pre-programs which nerves/muscles to be stimulated based on a clinical assessment of the user and the outcome is evaluated through standardized methods. The stimulation program is thus specific to each user.
Usual Care
The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced/adjusted to make time for initiation and follow-up of using the neuromodulation suit and potentially also during the weeks at home (i.e., rehabilitation being offered by municipalities).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately
* Diagnosis of multiple sclerosis.
Exclusion Criteria
* Change in disease modifying treatment within the last 3 months
* Use of Botuline Toxine A within the last 3months
* Recent relapse within the last 3 months
* Acute musculoskeletal problems that hinder the test performance,
* Pregnancy
* Sizes bigger than 3XL (triple eXtra Large)
* Skin eruptions and/or skin areas in the stimulation zone that are swollen, infected or inflamed.
18 Years
ALL
No
Sponsors
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Danish MS Hospitals, Haslev and Ry
OTHER
Universitair Ziekenhuis Brussel
OTHER
National MS Center Melsbroek
OTHER
Daphne Kos
OTHER
Responsible Party
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Daphne Kos
Professor
Principal Investigators
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Daphne Kos
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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Nationaal MS Center Melsbroek
Steenokkerzeel, , Belgium
The Danish MS Hospitals
Ry, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and Treatment of Multiple Sclerosis: A Review. JAMA. 2021 Feb 23;325(8):765-779. doi: 10.1001/jama.2020.26858.
Weller LJR, Sherwood SM, Ng SH, Vellaichamy M, Noordin AA, Tan LY, Mahadev A, Yeo TH, Ng ZM. Can External Neuromodulation Garments Improve Gait and Function in Children With Cerebral Palsy? A Prospective Single-Arm Study. Health Sci Rep. 2025 Mar 23;8(3):e70566. doi: 10.1002/hsr2.70566. eCollection 2025 Mar.
Skjerbaek AG, Dalgas U, Stenager E, Boesen F, Hvid LG. The six spot step test is superior in detecting walking capacity impairments compared to short- and long-distance walk tests in persons with multiple sclerosis. Mult Scler J Exp Transl Clin. 2023 Dec 12;9(4):20552173231218127. doi: 10.1177/20552173231218127. eCollection 2023 Oct-Dec.
Riemenschneider M, Trenel P, Norgaard M, Boesen F. Multimethodological validation of the modified fatigue impact scale in a Danish population of people with Multiple Sclerosis. Mult Scler Relat Disord. 2022 Sep;65:104012. doi: 10.1016/j.msard.2022.104012. Epub 2022 Jul 2.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
Perpetuini D, Russo EF, Cardone D, Palmieri R, De Giacomo A, Pellegrino R, Merla A, Calabro RS, Filoni S. Use and Effectiveness of Electrosuit in Neurological Disorders: A Systematic Review with Clinical Implications. Bioengineering (Basel). 2023 Jun 2;10(6):680. doi: 10.3390/bioengineering10060680.
Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.
Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.
Miller L, Mattison P, Paul L, Wood L. The effects of transcutaneous electrical nerve stimulation (TENS) on spasticity in multiple sclerosis. Mult Scler. 2007 May;13(4):527-33. doi: 10.1177/1352458506071509. Epub 2007 Jan 29.
Milinis K, Tennant A, Young CA; TONiC study group. Spasticity in multiple sclerosis: Associations with impairments and overall quality of life. Mult Scler Relat Disord. 2016 Jan;5:34-9. doi: 10.1016/j.msard.2015.10.007. Epub 2015 Oct 22.
Mai AS, Yong JH, Lim OZH, Tan EK. Non-invasive electrical stimulation in patients with neurodegenerative ataxia and spasticity: A systematic review and meta-analysis of randomized controlled trials. Eur J Neurol. 2022 Sep;29(9):2842-2850. doi: 10.1111/ene.15438. Epub 2022 Jun 27.
Learmonth YC, Motl RW, Sandroff BM, Pula JH, Cadavid D. Validation of patient determined disease steps (PDDS) scale scores in persons with multiple sclerosis. BMC Neurol. 2013 Apr 25;13:37. doi: 10.1186/1471-2377-13-37.
Jones AA, Purohit R, Bhatt T, Motl RW. Maintaining Mobility and Balance in Multiple Sclerosis: A Systematic Review Examining Potential Impact of Symptomatic Pharmacotherapy. CNS Drugs. 2025 Apr;39(4):361-382. doi: 10.1007/s40263-025-01159-7. Epub 2025 Feb 15.
Jakimovski D, Bittner S, Zivadinov R, Morrow SA, Benedict RH, Zipp F, Weinstock-Guttman B. Multiple sclerosis. Lancet. 2024 Jan 13;403(10422):183-202. doi: 10.1016/S0140-6736(23)01473-3. Epub 2023 Nov 7.
Hvid LG, Gaemelke T, Dalgas U, Slipsager MK, Rasmussen PV, Petersen T, Norgaard M, Skjerbaek AG, Boesen F. Personalised inpatient multidisciplinary rehabilitation elicits clinically relevant improvements in physical function in patients with multiple sclerosis - The Danish MS Hospitals Rehabilitation Study. Mult Scler J Exp Transl Clin. 2021 Feb 17;7(1):2055217321989384. doi: 10.1177/2055217321989384. eCollection 2021 Jan-Mar.
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
Hahn A, Moeller S, Schlausch A, Ekmann M, de Chelle G, Westerlund M, Braatz F, Mayr W. Effects of a full-body electrostimulation garment application in a cohort of subjects with cerebral palsy, multiple sclerosis, and stroke on upper motor neuron syndrome symptoms. Biomed Tech (Berl). 2023 Sep 12;69(1):49-59. doi: 10.1515/bmt-2023-0271. Print 2024 Feb 26.
Gijbels D, Dalgas U, Romberg A, de Groot V, Bethoux F, Vaney C, Gebara B, Medina CS, Maamagi H, Rasova K, de Noordhout BM, Knuts K, Feys P. Which walking capacity tests to use in multiple sclerosis? A multicentre study providing the basis for a core set. Mult Scler. 2012 Mar;18(3):364-71. doi: 10.1177/1352458511420598. Epub 2011 Sep 27.
Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.
Feys, P., Moghames, P., Kasilingam, E., King, R., Manacorda, T., Fonseca, M., Notas, K., & Kos, D. (2024). Prevalence, severity and impact of MS symptoms, and use of services in Europe: Results from the large scale IMSS survey. Multiple Sclerosis Journal, 30(3S), 1160.
Cameron MH, Wagner JM. Gait abnormalities in multiple sclerosis: pathogenesis, evaluation, and advances in treatment. Curr Neurol Neurosci Rep. 2011 Oct;11(5):507-15. doi: 10.1007/s11910-011-0214-y.
Callesen J, Richter C, Kristensen C, Sunesen I, Naesby M, Dalgas U, Skjerbaek AG. Test-retest agreement and reliability of the Six Spot Step Test in persons with multiple sclerosis. Mult Scler. 2019 Feb;25(2):286-294. doi: 10.1177/1352458517745725. Epub 2017 Dec 20.
Buckley E, Mazza C, McNeill A. A systematic review of the gait characteristics associated with Cerebellar Ataxia. Gait Posture. 2018 Feb;60:154-163. doi: 10.1016/j.gaitpost.2017.11.024. Epub 2017 Dec 1.
Boesen F, Norgaard M, Trenel P, Rasmussen PV, Petersen T, Lovendahl B, Sorensen J. Longer term effectiveness of inpatient multidisciplinary rehabilitation on health-related quality of life in MS patients: a pragmatic randomized controlled trial - The Danish MS Hospitals Rehabilitation Study. Mult Scler. 2018 Mar;24(3):340-349. doi: 10.1177/1352458517735188. Epub 2017 Oct 6.
Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009 Apr 27;7:36. doi: 10.1186/1477-7525-7-36.
Amatya B, Khan F, Song K, Galea M. Effectiveness of Non-Pharmacological Interventions for Spasticity Management in Multiple Sclerosis: A Systematic Review. Ann Rehabil Med. 2024 Oct;48(5):305-343. doi: 10.5535/arm.240064. Epub 2024 Oct 31.
Other Identifiers
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J5812540_2024
Identifier Type: -
Identifier Source: org_study_id
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