At Home Use of Stimulation Suits for Managing MS Symptoms
Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT
What it found
No result yet.
What was tested
Treatment tested
- electro-stimulation suit
- Usual Care
What it measured
Main measures
NHPT+SSST score
After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.
Other measures (14)
Six spot step test (SSST)
SSST assessment will take place after weeks 1 and 6 of stimulation.
Disability progressionWalking and mobilityNine Hole Peg Test (NHPT)
NHPT assessment will take place after weeks 1 and 6 of stimulation.
Modified Ashworth Scale (MAS)
MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.
SpasticityScale for the Assessment and Rating of Ataxia (SARA)
SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.
Walking and mobilityPhysical functionNumeric Rating Scale (NRS)
NRS assessments will take place after weeks 1 and 6 of stimulation.
Physical functionSpasticity6 Minute walk test
The assessment will take place after weeks 1 and 6 of stimulation.
Walking and mobility5 times sit to stand test (5STS)
The assessment will take place after weeks 1 and 6 of stimulation.
Walking and mobilityPhysical functionThe patient-Determined Disease Steps (PDDS)
PDDS assessment will take place after weeks 1 and 6 of stimulation.
Walking and mobilityThe 12-item Multiple Sclerosis Walking Scale (MSWS12)
MSWS-12 assessment will take place after weeks 1 and 6 of stimulation.
Walking and mobilityThe 36-item Manual Ability Measurement (MAM36)
MAM36 assessment will take place after weeks 1 and 6 of stimulation.
Arm and hand function
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Eligible participants must have ataxia or spasticity alongside impairments in upper or lower extremity physical function. MAS score ≥ 1 will be used as an inclusion criterion to determine the presence of spasticity. SARA score ≥ 4 will be used as an inclusion criterion to determine the presence of ataxia. Note: one of the two criteria (MAS score or SARA score) must be fulfilled for a pwMS to be eligible. * 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
* Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment ) * 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning. 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.
Papers
Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.Background
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.
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History
Started
Mar 2026
Main results due
Sept 2027
Finished
Sept 2027