Multiple SclerosisHANDS-MSNCT07202195
At Home Use of Stimulation Suits for Managing MS Symptoms
A study testing electro-stimulation suit in people with Multiple Sclerosis and MS (Multiple Sclerosis), run by Daphne Kos at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, MS (Multiple Sclerosis), Spasticity With Multiple Sclerosis
- What is being tested?
- electro-stimulation suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Alix-Anne Schreinemacher contact
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Nationaal MS Center Melsbroek
Steenokkerzeel, 1820
Daphne Kos, +32496107849, daphne.kos@uzbrussel.be
Alix-Anne Schreinemacher, alix-anne.schreinemacher@mscenter.be
Denmark1 site, 1 recruiting
- Recruiting
The Danish MS Hospitals
Ry, 8680
Lars Hvid, LARSHV@sclerosehospital.dk
About this study
Official title: Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT
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?
Read more
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.
- Conditions
- Multiple Sclerosis, MS (Multiple Sclerosis), Spasticity With Multiple Sclerosis, Ataxia - Other, Ataxia, Cerebellar, Ataxia, Motor
- Being tested
- electro-stimulation suit, Usual Care
- Keywords
- ataxia, spasticity, multiple sclerosis, MS, neuromodulation suit, stimulation suit, exopluse molli suit, home-based rehabilitation, symptom management
- Medical subject headings
- Multiple Sclerosis, Cerebellar Ataxia, Ataxia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-stimulation suitDevice
Also called neuromodulation suit, stimulation suit, EXOPULSE MOLLII 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 CareOther
Also called standard 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).
| Study group | Role | What they receive |
|---|---|---|
| stimulation suit group | Experimental | This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care. Receives: Device: electro-stimulation suit; Other: Usual Care |
| usual care | Other | This group will be a comparator and have no added intervention expect for their usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NHPT+SSST score
The primary outcome will be a combined measure of upper and lower extremity motor function, consisting of the Nine Hole Peg Test and the Six Spot step test (labelled NHPT+SSST score). Values are expressed in seconds.
A higher score, indicates a worse outcome.
Measured: After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.
Secondary outcomes (14)
Six spot step test (SSST)
Similar to the T25FW, the SSST is a quantitative measure of lower extremity function. The test contains a rectangular field with six circles on the floor following a criss-cross course. Five circles contain a block. The starting-point is the first circle, which does not contain a block. From there the patient walks to the other side of the field and kicks the blocks out of the five circles, as quickly as possible. The task is immediately administered again by having the patient walk back the same route. Both the dominant and non-dominant legs are tested twice.
The Maximum value: 300.0 seconds A higher score indicates a worse outcome.
Measured: SSST assessment will take place after weeks 1 and 6 of stimulation.
Nine Hole Peg Test (NHPT)
The Nine-Hole Peg Test (NHPT) is an assessment tool used to evaluate movement speed, particularly fine hand motor skills. The patient must take nine pegs from a container as quickly as possible and place them into the holes on a board. Afterwards, the patient must remove the pegs and return them to the container. The time taken to complete the task is measured. The patient may only use the hand being tested and must repeat the procedure for each peg individually (they are not allowed to pick up multiple pegs at once).
A higher score indicates a worse outcome.
Measured: NHPT assessment will take place after weeks 1 and 6 of stimulation.
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is designed to objectively assess the degree of spasticity. The MAS measures the level of hypertonia in the left and right elbows and knees. The therapist evaluates the muscle tone and records the highest level of tone felt during five repetitions per joint, using a six-point scale (0 = no increase in muscle tone, 4 = limb rigid in flexion or extension and cannot be moved).
A higher score indicates a worse outcome.
Measured: 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)
SARA is a clinical scale which assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.
The minimum value: 0 The maximum value: 40 A higher score indicates a worse outcome.
Measured: 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)
The severity of ataxia and spasticity will be documented bij a numeric scale. The minimum value: 0 The maximum value: 10 A higher score indicates a worse outcome.
Measured: NRS assessments will take place after weeks 1 and 6 of stimulation.
6 Minute walk test
The goal is for the participant to walk as many meters as possible within 6 minutes over a 30-meter course. The participant may use walking aids or foot orthoses. This test assesses the participant's functional capacity. The more meters walked, the better the functional capacity.
Measured: The assessment will take place after weeks 1 and 6 of stimulation.
5 times sit to stand test (5STS)
De Timed Chair Stand Test is a simple evaluative test used to assess, among other things, muscle strength, balance, and fall risk in older adults. During the Timed Chair Stand Test, the patient is asked to stand up from a chair and sit down again five times as quickly as possible, without using the arms. The physiotherapist records the time in seconds. A score greater than 14s indicates a fall risk.
Measured: The assessment will take place after weeks 1 and 6 of stimulation.
The patient-Determined Disease Steps (PDDS)
A questionnaire on how a person with MS preceives their capacity to walk. The patient needs to chose one descrition the reflects their condition the best.
The minimum value: 0 The maximum value: 8 A higher score, indicates a worse outcome.
Measured: PDDS assessment will take place after weeks 1 and 6 of stimulation.
The 12-item Multiple Sclerosis Walking Scale (MSWS12)
The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.
The minimum value: 0 The maximum value: 100 A higher score, indicate a worse outcome.
Measured: MSWS-12 assessment will take place after weeks 1 and 6 of stimulation.
The 36-item Manual Ability Measurement (MAM36)
The Manual Ability Measure (MAM) is designed as an outcome instrument to assess hand function based on the patient's responses to functional questions. Tasks are rated on a scale from 0 (cannot be done) to 4 (easy to do). Total scores range from 0 to 144.
A higher score indicates greater perceived manual ability.
Measured: MAM36 assessment will take place after weeks 1 and 6 of stimulation.
The EuroQol Questionnaire (EQ-D5)
The EQ-5D is a standardized instrument that provides a score across five health dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. (5 items, three or five response categories) In addition, the patient must indicate how they perceive their overall health status on a scale from 0 to 100. To interpret the results correctly, it is important that the healthcare provider is familiar with the patient's demographic information. (8 items) A higher score indicates a worse outcome.
Measured: 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)
Is used to evaluate treatment satisfaction with the particular aim of development and evaluation of treatment satisfaction among the patients already undergoing treatment. TSQM (1.4) has 14 questions divided into 4 subscales: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). Higher scores indicate a higher patient satisfaction with medication (Liberato et al. 2020). The questions have been re-formulated so they are applicable to using the stimulation suit.
Measured: The adapted TSQM 1.4 assessment will take place after weeks 1 and 6 of stimulation. Only for the intervention group
SymptoMScreen
A tool for rapid assessment of MS symptom ( the six most common areas where symptomatic complaints occur and are discussed during clinical visits) severity in routine clinical practice. It uses a 7-point Likert scales for each functional domain (0 = not affected at all, 6 = total limitation/I'm unable to do most daily activities).
The minimum value: 0 The maximum value: 72 A higher score indicates a worse outcome.
Measured: SymptoMScreen assessment will take place weekly from the start of the intervention until end of the study.
Modified Fatigue Impact Scales (MFIS)
The assessment will be used to assess the physical, cognitive, and psychosocial impact of fatigue. Each of the 21 items of the MFIS will be scored from 0-to-4, providing a total score ranging from 0 to 84 (higher scores, greater fatigue impact).
Measured: The assessment will take place after weeks 1 and 6 of stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start16 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daphne Kos
- Sponsor type
- University, hospital or other
- Collaborators
- Danish MS Hospitals, Haslev and Ry, Universitair Ziekenhuis Brussel, National MS Center Melsbroek
- Responsible party
- Sponsor-investigator, Daphne Kos, Universitair Ziekenhuis Brussel
- Investigators
- Daphne Kos, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202195
- Sponsor's protocol ID
- J5812540_2024
- Acronym
- HANDS-MS
- Status last verified
- Jan 2026
- First submitted
- 25 Aug 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40129510Skjerbaek 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.
PubMed 38105806Riemenschneider 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.
PubMed 35820358Rabin 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.
PubMed 11491192Perpetuini 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.
PubMed 37370612Palmcrantz 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.
PubMed 32778118Moller 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.
PubMed 22612360Miller 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.
PubMed 17463075Milinis 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.
PubMed 26856941McGinley 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.
PubMed 33620411Mai 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.
PubMed 35666142Learmonth 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.
PubMed 23617555Jones 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.
PubMed 39954116Jakimovski 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.
PubMed 37949093Hvid 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.
PubMed 33643662
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT
- ClinicalTrials.gov ID
- NCT07202195
- Acronym / sponsor ID
- HANDS-MS / J5812540_2024
- Conditions
- Multiple Sclerosis, MS (Multiple Sclerosis), Spasticity With Multiple Sclerosis, Ataxia - Other, Ataxia, Cerebellar, Ataxia, Motor
- Keywords
- ataxia, spasticity, multiple sclerosis, MS, neuromodulation suit, stimulation suit, exopluse molli suit, home-based rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Daphne KosUniversity, hospital or other
- Collaborators
- Danish MS Hospitals, Haslev and Ry, Universitair Ziekenhuis Brussel, National MS Center Melsbroek
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation suit group | Experimental | Device: electro-stimulation suit, Other: Usual CareThis group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care. |
| usual care | Other | Other: Usual CareThis group will be a comparator and have no added intervention expect for their usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electro-stimulation suitAlso: neuromodulation suit, stimulation suit, EXOPULSE MOLLII suitIn 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. | Device | stimulation suit group |
| Usual CareAlso: standard careThe 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 | stimulation suit group, usual care |
Primary outcome
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.
The primary outcome will be a combined measure of upper and lower extremity motor function, consisting of the Nine Hole Peg Test and the Six Spot step test (labelled NHPT+SSST score). Values are expressed in seconds. A higher score, indicates a worse outcome.
14 secondary outcomes
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
SymptoMScreen
Time frame: SymptoMScreen assessment will take place weekly from the start of the intervention until end of the study.
Modified Fatigue Impact Scales (MFIS)
Time frame: The assessment will take place after weeks 1 and 6 of stimulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 40129510Weller 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: PubMed 38105806Skjerbaek 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: PubMed 35820358Riemenschneider 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: PubMed 11491192Rabin 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: PubMed 37370612Perpetuini 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: PubMed 32778118Palmcrantz 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: PubMed 22612360Moller 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: PubMed 17463075Miller 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: PubMed 26856941Milinis 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: PubMed 33620411McGinley 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.
- Background: PubMed 35666142Mai 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.
- Background: PubMed 23617555Learmonth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alix-Anne Schreinemacher contact
Daphne Kos principal investigator
Universitair Ziekenhuis Brussel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electro-stimulation suit in people with Multiple Sclerosis and MS (Multiple Sclerosis), run by Daphne Kos at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphne Kos (+32496107849, daphne.kos@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07202195, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.