Multiple SclerosisEXO-MSNCT07897760
Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis
A study testing Electrostimulation suit in people with Multiple Sclerosis, run by Otto Bock Healthcare Products GmbH at 2 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Electrostimulation suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2026to 30 Nov 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS according to the 2024 McDonald criteria (Mon-talban et al. 2025).
- Age 18 - 70 years.
- Height 100 - 205 cm.
- No relapse within the last 6 months prior to study inclusion.
- No use of high-dose steroids or apheresis procedures within the last 3 months.
- Stable immunotherapy for the last 6 months prior to study inclu-sion in accordance with AAN (for U.S. sites) and DGN (for Ger-man sites) guidelines.
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- Spasticity with a score of at least 1+ on the MAS.
- EDSS score ≥ 4.0 and ≤ 6.5.
- EDSS pyramidal system score ≥ 2.
- BBS ≥15 and ≤ 48.
- Access to a smartphone capable of installing and operating the EXOPULSE App, and a stable internet connection in the stimula-tion environment. If the subject has a stable internet connection but does not own a suitable smartphone, a tablet may be provid-ed. In addition, the subject must be capable of independently us-ing the EXOPULSE App (e.g., navigating basic functions). Individ-uals who are unable to operate the App, even with instruction, should not be included.
- Ability to understand verbal instructions in German (for German sites) or English (for U.S. sites) language.
- Willingness and ability to independently provide, sign, and date the informed consent form.
Who cannot join
- Having a cardiac pacemaker or other contraindications to using EXOPULSE Suit.
- Participants for whom no existing EXOPULSE suit size provides an adequate fit.
- Not available for study visits during planned study duration.
- Prior use of the EXOPULSE Suit.
- Participation in any other interventional study or clinical investiga-tion within the past 4 weeks, current participation in another inter-ventional study or clinical investigation, or intention to participate in another interventional study or clinical investigation during the duration of this study.
- Initiation, discontinuation, or modification of any medication that could affect study outcomes within 4 weeks before screening, or any anticipated need to initiate, discontinue, or modify such medi-cation during the trial.
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- Change of medical treatment regimen or initiation of new medical therapy for spasticity 4 weeks before study inclusion, this also in-cludes admission of Fampridine (4-Aminopyridine).
- Initiation of physical therapy or a change in treatment intervals and/or intensity within 4 weeks before study inclusion.
- Having received botulinum toxin injections within 3 months before study inclusion, or who are expected or scheduled to receive botulinum toxin injections during the study period.
- Planned change of medical treatment regimen or planned medical intervention during this study's duration that could bias the study results (e.g. surgery, change in pharmacotherapy, initiation or completion of physical therapy).
- Being pregnant or breastfeeding.
- Clinically significant cardiac, metabolic, hematologic, hepatic, im-munologic, urologic, endocrinologic, neurologic, pulmonary, psy-chiatric, dermatologic, allergic, renal, gastrointestinal, or other ma-jor diseases that in the Investigator's judgment may affect inter-pretation of study results or participant safety.
- Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum dis-ease, Lyme disease, untreated Vitamin B12 deficiency, neurosar-coidosis, cerebrovascular disorders, and untreated hypothyroid-ism.
- Having a body mass index above 35 KG/m².
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
University Hospital Ulm, Dept. of Neurology
Ulm, 89081
Hayrettin Tumani, Prof. Dr. med., +49 731 500 63021, ms.studienzentrum@uniklinik-ulm.de
About this study
Official title: EXO-MS: Effect of the EXOPULSE Suit on Mobility, Walking, and Balance in Multiple Sclerosis: A Double-Blind, Controlled, Parallel-Group Trial
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.
Read more
Researchers will additionally evaluate the effects of the EXOPULSE Suit on:
- Pain
- Hand and finger dexterity
- Fatigue
- Quality of life
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Electrostimulation suit
- Keywords
- multiple sclerosis, electrostimulation, spasticity, movement disorders
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrostimulation suitDevice
Also called EXOPULSE 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The treatment group will receive regular stimulation for 60 minutes. Receives: Device: Electrostimulation suit |
| Sham control group | Sham comparator | The control group will receive stimulation with the sham software enabled. Receives: Device: Electrostimulation suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active treatment arm and sham/placebo treatment arm
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottobock SE & Co. KGaA, Exoneural Network AB, CW-Research & Management GmbH, Otto Bock HealthCare LP
- Responsible party
- Sponsor
- Investigators
- Hayrettin Tumani, Prof. Dr. med., Principal investigator, University Hospital Ulm, Dept. of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897760
- Sponsor's protocol ID
- PS00011431B-001
- Other IDs
- CIV-26-06-058655
- Acronym
- EXO-MS
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Reason: participant privacy and data protection restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXO-MS: Effect of the EXOPULSE Suit on Mobility, Walking, and Balance in Multiple Sclerosis: A Double-Blind, Controlled, Parallel-Group Trial
- ClinicalTrials.gov ID
- NCT07897760
- Acronym / sponsor ID
- EXO-MS / PS00011431B-001
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, electrostimulation, spasticity, movement disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Ottobock SE & Co. KGaA, Exoneural Network AB, CW-Research & Management GmbH, Otto Bock HealthCare LP
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Oct 2026 (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 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:
- Pain
- Hand and finger dexterity
- Fatigue
- Quality of life
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active treatment arm and sham/placebo treatment arm
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Electrostimulation suitThe treatment group will receive regular stimulation for 60 minutes. |
| Sham control group | Sham comparator | Device: Electrostimulation suitThe control group will receive stimulation with the sham software enabled. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of MS according to the 2024 McDonald criteria (Mon-talban et al. 2025).
- Age 18 - 70 years.
- Height 100 - 205 cm.
- No relapse within the last 6 months prior to study inclusion.
- No use of high-dose steroids or apheresis procedures within the last 3 months.
Key exclusion criteria (14 listed)
- Having a cardiac pacemaker or other contraindications to using EXOPULSE Suit.
- Participants for whom no existing EXOPULSE suit size provides an adequate fit.
- Not available for study visits during planned study duration.
- Prior use of the EXOPULSE Suit.
- Participation in any other interventional study or clinical investiga-tion within the past 4 weeks, current participation in another inter-ventional study or clinical investigation, or intention to participate in another interventional study or clinical investigation during the duration of this study.
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 |
|---|---|---|
| Electrostimulation suitAlso: EXOPULSE SuitOne 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. | Device | Sham control group, Treatment |
Primary outcome
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.
Time frame: 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.
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.
Time frame: 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.
3 secondary outcomes
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.
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.
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.
Time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Reason: participant privacy and data protection restrictions.
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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.
Hayrettin Tumani, Prof. Dr. med. principal investigator
University Hospital Ulm, Dept. of Neurology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrostimulation suit in people with Multiple Sclerosis, run by Otto Bock Healthcare Products GmbH 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 13 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 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 United States, Germany. 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. Some participants in this study may receive a placebo. 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 Pawel Maciejasz, PhD (+4955278483054, pawel.maciejasz@ottobock.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.