An interventional study of Electrostimulation suit in Multiple Sclerosis, sponsored by Otto Bock Healthcare Products GmbH. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Otto Bock Healthcare Products GmbH · Not applicable, Interventional, and Treatment
This clinical research study is investigating whether the EXOPULSE Suit, a wearable device that delivers electrical stimulation, can help improve movement difficulties caused by spasticity in adults with multiple sclerosis (MS).
The main goal of the study is to evaluate the effect of the EXOPULSE Suit on functional mobility, with particular focus on walking ability and balance. The study will also assess the safety of the device by monitoring any adverse events that occur during the study.
Researchers will additionally evaluate the effects of the EXOPULSE Suit on:
Participants will be randomly assigned to receive one of the stimulation programs being evaluated in the study. Some participants may receive a sham (placebo) stimulation. Neither the participants nor the study staff performing the assessments will know which stimulation program a participant has been assigned to during the study. This approach, known as blinding, helps ensure that the study results are as objective and reliable as possible.
Participants will use the EXOPULSE Suit for one hour every other day during a 4-week home-use period. Clinical assessments will be performed before and after the treatment period to evaluate changes in mobility and other symptoms.
It is important to note that individuals may experience the stimulation differently. Some participants may clearly feel the stimulation, while others may feel it only slightly or not at all. Not feeling the stimulation does not necessarily indicate which study group a participant has been assigned to, and a treatment effect may still be possible even when the stimulation is not perceived.
To ensure meaningful study results, participants are encouraged to use the EXOPULSE Suit as instructed throughout the study period, even if they do not notice a sensation of stimulation or an immediate improvement in their symptoms.
The study uses an adaptive design, meaning that an interim analysis will be performed during the study to determine the number of participants needed to reliably evaluate the study objectives.
The final sample size will be between 70 and 100, determined by the response rate and effect size, and will be defined after an IA was conducted once the first 50 participants have completed the study.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Otto Bock Healthcare Products GmbH is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment group will receive regular stimulation for 60 minutes.
Device: Electrostimulation suit
The control group will receive stimulation with the sham software enabled.
Device: Electrostimulation suit
One hour stimulation with an electrostimulation suit every other day. The EXOPULSE Suit provides low-intensity sensory electrical stimulation below the motor threshold. Unlike neuromuscular electrical stimulation (NMES), it is not intended to induce muscle contractions. The stimulation is conceptually similar to TENS but is delivered at lower intensities.
Also known as: EXOPULSE Suit
Balance responder rate: Percentage of patients achieving a clinically meaningful improvement in balance, as measured by the Berg Balance Scale (BBS), in the treatment group compared with sham-control group.
Percentage of patients achieving a clinically meaningful improvement in balance, defined as a ≥6-point improvement from baseline 1 on the Berg Balance Scale (BBS) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The Berg Balance Scale (BBS) is a 14-item clinical assessment designed to evaluate static and dynamic balance during functional tasks. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with a total score range of 0 to 56. Higher scores indicate better balance performance and lower fall risk, while lower scores indicate greater balance impairment. Points are deducted when a task cannot be completed independently, requires supervision or assistance, or does not meet the specified performance criteria. The BBS assesses balance during activities such as sitting, standing, transferring, reaching, turning, and single-leg stance.
Time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Walking responder rate: Percentage of patients achieving a clinically meaningful improvement in walking ability, on the transformed 0-100 Multiple Sclerosis Walking Scale-12 (MSWS-12), in the treatment group compared with the sham -control group.
Percentage of patients achieving a clinically meaningful improvement in walking ability, defined as a ≥8-point decrease from baseline 1 on the transformed 0-100 Multi-ple Sclerosis Walking Scale-12 (MSWS-12) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The MSWS-12 is a self-report questionnaire designed to assess the impact of MS on an individual's walking ability. It consists of 12 items, each rated on a scale from 1 to 5, where 1 indicates no limitation, and 5 indicates extreme limitation. The items cover various aspects of walking, e.g.: ability to walk and run, climbing stairs, standing balance, walking distance and speed, effort required for walking. The total score is calculated by summing up the responses, which can then be transformed to a scale from 0 to 100, with higher scores indicating a greater impact on walking ability.
Time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Walking endurance responder rate: Percentage of patients achieving a clinically meaningful improvement in walking endurance, as measured by the 6-Minute Walk Test (6MWT), in the treatment group compared with the sham-control group.
Percentage of patients achieving a clinically meaningful improvement in walking endurance, defined as a ≥19.7-meter increase from baseline 1 on the 6-Minute Walk Test (6MWT) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The 6-minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endur-ance. The subject is asked to walk as far as possible for 6 minutes on a predefined track. The dis-tance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
MS impact responder rate: Percentage of patients achieving a clinically meaningful improvement in the impact of multiple sclerosis on daily life, as measured by the MSIS-29, in the treatment group compared with the sham-control group.
Percentage of patients achieving a clinically meaningful improvement in the impact of multiple sclerosis on daily life, defined as a ≥9.1-point decrease from baseline 1 on the Physical subscale and a ≥5.5-point decrease from base-line 1 on the Psychological subscale of the Multiple Sclerosis Impact Scale-29 (MSIS-29) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. MSIS-29 is a self-report questionnaire designed to measure the impact of Multiple Sclerosis (MS) on a person's daily life. It consists of 29 items divided into two subscales: physical impact (20 items) and psychological impact (9 items). Each item is rated on a scale from 1 (not at all) to 5 (extremely), reflecting the extent to which MS affects various aspects of daily functioning. The scores for each subscale are summed and then transformed to a 0-100 scale, with higher scores indicating a greater impact of MS
Time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Health-related quality-of-life responder rate: Percentage of patients achieving a clinically meaningful improvement in health-related quality of life, as measured by the EQ-5D-5L Utility Index, in the treatment group compared with the sham-control group.
Percentage of patients achieving a clinically meaningful improve-ment in health-related quality of life, defined as an improvement from baseline 1 in the EQ-5D-5L Utility Index meeting or exceed-ing the subtype-specific minimal important change (MIC) thresh-old after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The EQ-5D-5L is a standardized measure of health-related quality of life consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from no problems to extreme problems. Responses are combined into a health state that can be converted into a utility index score from less than 0 (worse than death) to 1 (perfect quality of live), with higher scores indicating better health-related quality of life. The EQ-5D-5L also includes a visual analogue scale (EQ VAS) ranging from 0 to 100, with higher scores better.
Time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Walking ability as measured by Timed 25-Foot Walk Test (T25FW)
The T25FW measures walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible, with the time recorded. Faster times indicate better mobility and gait function. It is widely used in MS clinical studies to assess ambulatory performance.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Mobility and dynamic balance as measured by Six Spot Step Test (SSST)
The Six Spot Step Test (SSST) is a performance-based measure of walking ability, agility, and lower-extremity motor control. During the test, participants walk along a designated path while moving six objects from marked circles using their feet. The outcome is the time required to complete the task, measured in seconds. Lower times indicate better performance, whereas higher times indicate greater impairment in walking and coordination.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Finger dexterity as measured by 9-Hole Peg Test (9HPT)
The 9-Hole Peg Test (9HPT) is a standardized measure of fine motor function and manual dexterity of the upper extremities. During the test, participants place nine pegs into nine holes and then remove them as quickly as possible. The outcome is the time required to complete the task, measured in seconds. Lower times indicate better manual dexterity, whereas higher times indicate greater impairment of hand function.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Perceived physical impact of multiple sclerosis on a patient's daily life, as measured by the MSIS-29 Physical Impact Subscale
The Multiple Sclerosis Impact Scale - 29 Physical Impact Subscale (MSIS-29 PHYS) is a patient-reported measure of the physical impact of multiple sclerosis on daily life. The subscale comprises 20 items evaluating limitations in physical functioning. The total score ranges from 20 to 100, with higher scores indicating greater physical impact of multiple sclerosis and worse physical functioning, and lower scores indicating less physical impact and better physical functioning.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Perceived psychological impact of multiple sclerosis on a patient's daily life, as measured by the MSIS-29 Psychological Impact Sub-scale
The Multiple Sclerosis Impact Scale - 29 Psychological Impact Subscale (MSIS-29 PSYCH) is a patient-reported measure of the psychological impact of multiple sclerosis on daily life. The subscale comprises 9 items evaluating aspects such as emotional well-being, anxiety, and depression. The total score ranges from 9 to 45, with higher scores indicating greater psychological impact of multiple sclerosis and poorer psychological well-being, and lower scores indicating less psychological impact and better psychological well-being.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Perceived balance as measured by Falls Efficacy Scale - International (FES-I)
The Falls Efficacy Scale-International (FES-I) is a patient-reported measure of concern about falling during a range of daily activities. The questionnaire consists of 16 items, each scored from 1 (not at all concerned) to 4 (very concerned), resulting in a total score ranging from 16 to 64. Higher scores indicate greater concern about falling, whereas lower scores indicate less concern and greater confidence in performing daily activities without falling.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Perceived psychological symptoms of anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a patient-reported measure of symptoms of anxiety and depression. It consists of 14 items divided into two subscales: Anxiety (HADS-A) and Depression (HADS-D), each comprising 7 items. Each subscale is scored from 0 to 21, with higher scores indicating greater anxiety or depression symptoms. The total HADS score ranges from 0 to 42, with higher scores indicating greater overall psychological distress.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Fatigue as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)
The Fatigue Scale for Motor and Cognitive Functions (FSMC) is a patient-reported measure of fatigue in individuals with neurological disorders. It consists of 20 items divided into two subscales assessing motor fatigue and cognitive fatigue. The total score ranges from 20 to 100, with higher scores indicating greater fatigue and lower scores indicating less fatigue. Subscale scores range from 10 to 50, with higher scores indicating greater motor or cognitive fatigue, respective
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Pain as measured on 0-10 Numeric Rating Scale (NRS-11)
The Numeric Rating Scale (NRS-11) for pain is a patient-reported measure of pain intensity. Participants rate their pain on an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity, whereas lower scores indicate less pain.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Patient reported spasticity severity as measured on Numeric Rating Scale (NRS-11)
The Numeric Rating Scale (NRS-11) for spasticity is a patient-reported measure of spasticity severity. Participants rate the severity of their spasticity on an 11-point scale ranging from 0 to 10, where 0 indicates no spasticity and 10 indicates the most severe spasticity imaginable. Higher scores indicate greater spasticity severity, whereas lower scores indicate less severe spasticity.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Bladder/Intestine part of the HALEMS 10 questionnaire
The Hamburger Lebensqualitätsfragebogen bei Multipler Sklerose (HALEMS 10) is a patient-reported measure of health-related quality of life in individuals with multiple sclerosis. It comprises 10 domains assessing physical, psychological, cognitive, and social aspects of functioning. The Bladder/Intestine domain compromises 3 questions rated on a 5-point scale ranging from 1 (not affected at all) to 5 (very severely affected). The lower the score the better.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Change in biomarker level to assess Nervus Vagus activation and neuromuscular junction integrity (serum Neurofilament light chain, sNfL)
Serum Neurofilament Light Chain (sNfL) is a blood-based biomarker of neuroaxonal injury. The outcome measure is the change in sNfL concentration from baseline to the specified assessment time point. Results shall be reported as absolute concentrations (pg/mL) and as age-adjusted z-scores derived from validated reference data appropriate to the assay and sample matrix. Where applicable, additional covariates, such as body mass index, shall be incorporated according to the selected reference model. The assay and z-score calculation method shall be prespecified and applied consistently throughout the study. The same analytical platform should be used for all longitudinal measurements
Time frame: From the study start to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Participant's self-rated overall health status as measured by the EQ-5D-5L Visual Analogue Scale (EQ VAS).
The EQ VAS is a visual analogue scale on which participants rate their overall health status on the day of assessment. Scores range from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"), with higher scores indicating better perceived health.
Time frame: Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days)
Participant's perceived overall change in health status as measured by the Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) is a patient-reported measure that assesses the participant's overall perception of change in their condition since the start of treatment. Participants rate their improvement or worsening on a 7-point scale from "very much worse" to "very much improved".
Time frame: From first device use in the study to the post-treatment assessment conducted after 28 days of treatment, with an allowed assessment window of -3 to +10 days.
Disability in Multiple Sclerosis as measured by Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a clinician-rated measure of neurological disability in multiple sclerosis, ranging from 0 (normal neurological status) to 10 (death due to MS), with higher scores indicating greater disability.
Time frame: Change from study inclusion to the post-treatment assessment conducted after 28 days of treatment, with an allowed assessment window of -3 to +10 days.
Plan to share: No — Reason: participant privacy and data protection restrictions.
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Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 869 interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Otto Bock Healthcare Products GmbH