Trial · NCT07897760
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | 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. |
| Primary | 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. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | 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. |
| Secondary | 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. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | 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. |
| Secondary | 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. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | 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 |
| Secondary | 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. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | 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. |
| Other | Walking ability as measured by Timed 25-Foot Walk Test (T25FW) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Mobility and dynamic balance as measured by Six Spot Step Test (SSST) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Finger dexterity as measured by 9-Hole Peg Test (9HPT) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Perceived physical impact of multiple sclerosis on a patient's daily life, as measured by the MSIS-29 Physical Impact Subscale | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Perceived psychological impact of multiple sclerosis on a patient's daily life, as measured by the MSIS-29 Psychological Impact Sub-scale | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Perceived balance as measured by Falls Efficacy Scale - International (FES-I) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Perceived psychological symptoms of anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Fatigue as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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 |
| Other | Pain as measured on 0-10 Numeric Rating Scale (NRS-11) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Patient reported spasticity severity as measured on Numeric Rating Scale (NRS-11) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Bladder/Intestine part of the HALEMS 10 questionnaire | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Change in biomarker level to assess Nervus Vagus activation and neuromuscular junction integrity (serum Neurofilament light chain, sNfL) | From the study start to the post-treatment assessment after 28 days of treatment (-3/+10 days). | 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 |
| Other | Participant's self-rated overall health status as measured by the EQ-5D-5L Visual Analogue Scale (EQ VAS). | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | 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. |
| Other | Participant's perceived overall change in health status as measured by the Patient Global Impression of Change (PGIC) | 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. | 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". |
| Other | Disability in Multiple Sclerosis as measured by Expanded Disability Status Scale (EDSS) | 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. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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