At Home Use of Stimulation Suits for Managing MS Symptoms

Official title

Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT

Overview

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.

Interventions

• Device 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 diffe
• Other 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).

Primary outcome measures

• NHPT+SSST score [Time frame: After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.]

Secondary outcome measures (12)

• Six spot step test (SSST) [Time frame: SSST assessment will take place after weeks 1 and 6 of stimulation.]
• Nine Hole Peg Test (NHPT) [Time frame: NHPT assessment will take place after weeks 1 and 6 of stimulation.]
• Modified Ashworth Scale (MAS) [Time frame: MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.]
• Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.]
• Numeric Rating Scale (NRS) [Time frame: NRS assessments will take place after weeks 1 and 6 of stimulation.]
• 6 Minute walk test [Time frame: The assessment will take place after weeks 1 and 6 of stimulation.]
• 5 times sit to stand test (5STS) [Time frame: The assessment will take place after weeks 1 and 6 of stimulation.]
• The patient-Determined Disease Steps (PDDS) [Time frame: PDDS assessment will take place after weeks 1 and 6 of stimulation.]
• The 12-item Multiple Sclerosis Walking Scale (MSWS12) [Time frame: MSWS-12 assessment will take place after weeks 1 and 6 of stimulation.]
• The 36-item Manual Ability Measurement (MAM36) [Time frame: MAM36 assessment will take place after weeks 1 and 6 of stimulation.]
• The EuroQol Questionnaire (EQ-D5) [Time frame: EQ-5D assessment will take place after weeks 1 and 6 of stimulation.]
• adapted Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM 1.4) [Time frame: The adapted TSQM 1.4 assessment will take place after weeks 1 and 6 of stimulation. Only for the intervention group]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Belgium · 1 center

• Nationaal MS Center Melsbroek — Steenokkerzeel

Denmark · 1 center

• The Danish MS Hospitals — Ry

Publications

• 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. PMID 40129510
• 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. PMID 38105806
• 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. PMID 35820358
• 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. PMID 11491192
• 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. PMID 37370612
• 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. PMID 32778118
• 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. PMID 22612360
• 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. PMID 17463075

Identifiers

NCT: NCT07202195 · J5812540_2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗