Multiple SclerosisTMS-SPASMSNCT07786506
Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Pain in Multiple Sclerosis
A study testing Active Intermittent Theta-Burst Stimulation (iTBS) in people with Multiple Sclerosis and Muscle Spasticity, run by Comenius University at 1 site in Slovakia.
Trial summary
Spasticity and neuropathic pain are frequent and disabling symptoms of multiple sclerosis. Intermittent theta-burst stimulation (iTBS) is a non-invasive neuromodulation technique that may modulate cortical and corticospinal excitability and thereby improve motor symptoms and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Muscle Spasticity, Neuropathic Pain
- What is being tested?
- Active Intermittent Theta-Burst Stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSlovakia
- Study dates
- 10 Aug 2026to 31 Oct 2026
- 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
- Diagnosis of multiple sclerosis according to the 2024 McDonald criteria.
- Expanded Disability Status Scale (EDSS) score from 2.5 to 6.0.
- Clinically significant spasticity in at least one muscle group of the more affected lower limb, defined as a Modified Tardieu Scale quality of muscle reaction score of at least 2 at velocity V3.
- Lower-limb pain intensity of at least 4/10 on a 0-10 Visual Analogue Scale at screening.
- Stable pharmacological treatment, including disease-modifying therapy, for at least 3 months before enrolment.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Epilepsy or another condition associated with an increased risk of seizure.
- Metallic implants, implanted electronic devices, or other conditions contraindicating transcranial magnetic stimulation.
- Clinical relapse of multiple sclerosis within 30 days before enrolment.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site
2nd Department of Neurology, Faculty of Medicine, Comenius University Bratislava and University Hospital Bratislava
Bratislava, 83305
Peter Musil, PhD., +421903836788, musil.p@gmail.com
About this study
Official title: A Randomized, Sham-Controlled, Assessor-Blinded Study of Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Neuropathic Pain in Patients With Multiple Sclerosis
Spasticity and neuropathic pain are frequent and disabling symptoms of multiple sclerosis. Intermittent theta-burst stimulation (iTBS) is a non-invasive neuromodulation technique that may modulate cortical and corticospinal excitability and thereby improve motor symptoms and pain. This randomized, parallel-group, sham-controlled, assessor-blinded study will evaluate the clinical efficacy of active iTBS compared with sham stimulation in adults with multiple sclerosis and clinically significant lower-limb spasticity and pain. Participants will receive five stimulation sessions over one week. Spasticity, pain, patient-reported outcomes, and the electrophysiological H/M ratio will be assessed at baseline and at Weeks 2 and 4 after the intervention.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. Lower-limb spasticity and neuropathic pain can substantially impair mobility, daily functioning, and quality of life. Current symptomatic treatments include oral antispastic medication and targeted botulinum toxin type A injections, but their effects may be incomplete or time-limited. Intermittent theta-burst stimulation is a repetitive transcranial magnetic stimulation protocol with the potential to modulate cortical and corticospinal excitability.
The study will determine whether active iTBS applied over the primary motor cortex produces a greater reduction in lower-limb spasticity and neuropathic pain than sham iTBS in patients with MS.
This is a randomized, two-arm, parallel-group, sham-controlled, assessor-blinded clinical study conducted at the Multiple Sclerosis Centre of the 2nd Department of Neurology, Faculty of Medicine, Comenius University Bratislava and University Hospital Bratislava. Eligible participants will be randomized to active iTBS or sham iTBS. Stimulation will target the primary motor cortex contralateral to the more affected lower limb and the cortical representation of the muscle group corresponding to the dominant spastic pattern, identified using motor-evoked potentials and neuronavigation. Participants will undergo five sessions on consecutive weekdays. The active protocol comprises 1,200 pulses per day, delivered as two 600-pulse blocks separated by a 15-minute inter-block interval.
Clinical and neurophysiological assessments will be performed at baseline and at Weeks 2 and 4 after the intervention by an assessor blinded to treatment allocation. Assessments include the Tardieu Scale, pain measures, MS-specific quality-of-life and symptom questionnaires, and the H/M ratio measured by electromyography. Participants with a persistent clinical indication after completion of the four-week follow-up may receive botulinum toxin type A as standard-of-care rescue treatment.
- Conditions
- Multiple Sclerosis, Muscle Spasticity, Neuropathic Pain
- Being tested
- Active Intermittent Theta-Burst Stimulation (iTBS), Sham Intermittent Theta-Burst Stimulation
- Keywords
- multiple sclerosis, lower-limb spasticity, neuropathic pain, intermittent theta-burst stimulation, iTBS, repetitive transcranial magnetic stimulation, rTMS, motor cortex, H-reflex, H/M ratio
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Intermittent Theta-Burst Stimulation (iTBS)Device
Active iTBS will be delivered using a Neuro-MS/D Advanced Therapeutic magnetic stimulator (Neurosoft) with a figure-of-eight coil. The stimulation target will be the representation of the muscle group corresponding to the dominant spastic pattern of the more affected lower limb in the contralateral primary motor cortex. The target will be identified using motor-evoked potentials and neuronavigation based on the participant's individual MRI. Active motor threshold will be determined from the tibialis anterior muscle. Stimulation intensity will be set at 80% of the active motor threshold. Each burst will consist of 3 pulses at 50 Hz, repeated at 5 Hz. Each 600-pulse block will use a 2-second on/8-second off pattern and last approximately 3 minutes 9 seconds. Two 600-pulse blocks will be delivered per day, separated by a 15-minute interval, for a total of 1,200 pulses per day. Treatment will be administered on five consecutive weekdays, giving 10 stimulation blocks in total.
Sham Intermittent Theta-Burst StimulationDevice
In both groups, the TMS coil will be positioned over the primary motor cortex representation of the more affected lower limb and sham electrodes will be attached to the forehead. During sham stimulation, surface electrodes placed on the forehead will deliver low-intensity electrical stimulation at 2 mA to reproduce the somatosensory experience of TMS. The TMS device will simultaneously produce the characteristic clicking sound of coil discharge. The software will conceal the assigned mode from the participant and stimulation operator. The visit schedule, positioning, and total procedural duration will match the active condition.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS | Experimental | Participants will receive active intermittent theta-burst stimulation over the primary motor cortex contralateral to the more affected lower limb. Receives: Device: Active Intermittent Theta-Burst Stimulation (iTBS) |
| sham iTBS | Sham comparator | Participants will receive sham stimulation over the same cortical target and according to the same visit schedule as the active group. Receives: Device: Sham Intermittent Theta-Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Tardieu Scale Quality of Muscle Reaction Score
The entire more affected lower limb will be examined using the Modified Tardieu Scale. At baseline, the muscle group corresponding to the dominant spastic pattern will be predefined as the individual target muscle group and the same muscle group will be reassessed at all subsequent visits. The quality of muscle reaction at fast stretch velocity V3 is scored from 0 to 5, where 0 indicates no resistance and higher scores indicate a more pronounced catch or clonus; a lower score indicates less spasticity.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Worst Lower-Limb Pain Intensity on the Numeric Rating Scale
Participants will rate the worst pain intensity experienced in the affected lower limb during the preceding 14 days on an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Secondary outcomes (12)
Neuropathic Pain Features Measured by the Douleur Neuropathique 4 Questionnaire
The Douleur Neuropathique 4 (DN4) questionnaire will be scored from 0 to 10. Higher scores indicate more neuropathic pain features; a score of 4 or more supports the presence of neuropathic pain.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Impact Scale - Physical Impact Score
The physical-impact subscale of the Multiple Sclerosis Impact Scale version 2 will be transformed to a 0-100 score. Higher scores indicate a greater physical impact of MS.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Impact Scale - Psychological Impact Score
The psychological-impact subscale of the Multiple Sclerosis Impact Scale version 2 will be transformed to a 0-100 score. Higher scores indicate a greater psychological impact of MS.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Quality of Life-54 - Physical Health Composite Score
The Physical Health Composite of the Multiple Sclerosis Quality of Life-54 will be scored from 0 to 100. Higher scores indicate better health-related quality of life.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Quality of Life-54 - Mental Health Composite Score
The Mental Health Composite of the MSQOL-54 will be scored from 0 to 100. Higher scores indicate better health-related quality of life.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Fatigue Scale for Motor and Cognitive Functions Total Score
The Fatigue Scale for Motor and Cognitive Functions total score ranges from 20 to 100. Higher scores indicate more severe fatigue.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Hospital Anxiety and Depression Scale - Anxiety Subscale Score
The Hospital Anxiety and Depression Scale Anxiety subscale ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Hospital Anxiety and Depression Scale - Depression Subscale Score
The Hospital Anxiety and Depression Scale Depression subscale ranges from 0 to 21. Higher scores indicate more severe depressive symptoms.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Neuropsychological Screening Questionnaire Score
The patient-report Multiple Sclerosis Neuropsychological Screening Questionnaire total score ranges from 0 to 60. Higher scores indicate greater perceived neuropsychological impairment.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Patient-Determined Disease Steps Score
The Patient-Determined Disease Steps score ranges from 0 (normal) to 8 (bedridden). Higher scores indicate greater walking disability.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
H/M Ratio as a Neurophysiological Marker of Spinal Excitability
The H-reflex will be elicited by stimulation of the tibial nerve and recorded from the soleus muscle. The maximal H-reflex amplitude will be divided by the maximal M-wave amplitude and expressed as Hmax/Mmax × 100%. The same limb, electrode placement, and acquisition protocol will be used at all visits.
Measured: Baseline, Week 2, and Week 4 after the final stimulation session
Treatment-Emergent Adverse Events
Number and proportion of participants experiencing any treatment-emergent adverse event during the stimulation week and follow-up. Events will be recorded by type, severity, seriousness, and relationship to the stimulation procedure.
Measured: From the first stimulation session through Week 4 after the final stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (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
- Forty participants will be assigned in a 1:1 ratio to active iTBS (n=20) or sham iTBS (n=20).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Valkovič, prof. MD PhD., Principal investigator, Faculty of Medicine, Comenius University Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786506
- Sponsor's protocol ID
- TMS-SPASMS-01
- Acronym
- TMS-SPASMS
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled, Assessor-Blinded Study of Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Neuropathic Pain in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07786506
- Acronym / sponsor ID
- TMS-SPASMS / TMS-SPASMS-01
- Conditions
- Multiple Sclerosis, Muscle Spasticity, Neuropathic Pain
- Keywords
- multiple sclerosis, lower-limb spasticity, neuropathic pain, intermittent theta-burst stimulation, iTBS, repetitive transcranial magnetic stimulation, rTMS, motor cortex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Aug 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.
Spasticity and neuropathic pain are frequent and disabling symptoms of multiple sclerosis. Intermittent theta-burst stimulation (iTBS) is a non-invasive neuromodulation technique that may modulate cortical and corticospinal excitability and thereby improve motor symptoms and pain. This randomized, parallel-group, sham-controlled, assessor-blinded study will evaluate the clinical efficacy of active iTBS compared with sham stimulation in adults with multiple sclerosis and clinically significant lower-limb spasticity and pain. Participants will receive five stimulation sessions over one week. Spasticity, pain, patient-reported outcomes, and the electrophysiological H/M ratio will be assessed at baseline and at Weeks 2 and 4 after the intervention.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. Lower-limb spasticity and neuropathic pain can substantially impair mobility, daily functioning, and quality of life. Current symptomatic treatments include oral antispastic medication and targeted botulinum toxin type A injections, but their effects may be incomplete or time-limited. Intermittent theta-burst stimulation is a repetitive transcranial magnetic stimulation protocol with the potential to modulate cortical and corticospinal excitability.
The study will determine whether active iTBS applied over the primary motor cortex produces a greater reduction in lower-limb spasticity and neuropathic pain than sham iTBS in patients with MS.
This is a randomized, two-arm, parallel-group, sham-controlled, assessor-blinded clinical study conducted at the Multiple Sclerosis Centre of the 2nd Department of Neurology, Faculty of Medicine, Comenius University Bratislava and University Hospital Bratislava. Eligible participants will be randomized to active iTBS or sham iTBS. Stimulation will target the primary motor cortex contralateral to the more affected lower limb and the cortical representation of the muscle group corresponding to the dominant spastic pattern, identified using motor-evoked potentials and neuronavigation. Participants will undergo five sessions on consecutive weekdays. The active protocol comprises 1,200 pulses per day, delivered as two 600-pulse blocks separated by a 15-minute inter-block interval.
Clinical and neurophysiological assessments will be performed at baseline and at Weeks 2 and 4 after the intervention by an assessor blinded to treatment allocation. Assessments include the Tardieu Scale, pain measures, MS-specific quality-of-life and symptom questionnaires, and the H/M ratio measured by electromyography. Participants with a persistent clinical indication after completion of the four-week follow-up may receive botulinum toxin type A as standard-of-care rescue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Forty participants will be assigned in a 1:1 ratio to active iTBS (n=20) or sham iTBS (n=20).
| Arm | Type | Receives |
|---|---|---|
| active iTBS | Experimental | Device: Active Intermittent Theta-Burst Stimulation (iTBS)Participants will receive active intermittent theta-burst stimulation over the primary motor cortex contralateral to the more affected lower limb. |
| sham iTBS | Sham comparator | Device: Sham Intermittent Theta-Burst StimulationParticipants will receive sham stimulation over the same cortical target and according to the same visit schedule as the active group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of multiple sclerosis according to the 2024 McDonald criteria.
- Expanded Disability Status Scale (EDSS) score from 2.5 to 6.0.
- Clinically significant spasticity in at least one muscle group of the more affected lower limb, defined as a Modified Tardieu Scale quality of muscle reaction score of at least 2 at velocity V3.
- Lower-limb pain intensity of at least 4/10 on a 0-10 Visual Analogue Scale at screening.
- Stable pharmacological treatment, including disease-modifying therapy, for at least 3 months before enrolment.
Key exclusion criteria (4 listed)
- Epilepsy or another condition associated with an increased risk of seizure.
- Metallic implants, implanted electronic devices, or other conditions contraindicating transcranial magnetic stimulation.
- Clinical relapse of multiple sclerosis within 30 days before enrolment.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Active Intermittent Theta-Burst Stimulation (iTBS)Active iTBS will be delivered using a Neuro-MS/D Advanced Therapeutic magnetic stimulator (Neurosoft) with a figure-of-eight coil. The stimulation target will be the representation of the muscle group corresponding to the dominant spastic pattern of the more affected lower limb in the contralateral primary motor cortex. The target will be identified using motor-evoked potentials and neuronavigation based on the participant's individual MRI. Active motor threshold will be determined from the tibialis anterior muscle. Stimulation intensity will be set at 80% of the active motor threshold. Each burst will consist of 3 pulses at 50 Hz, repeated at 5 Hz. Each 600-pulse block will use a 2-second on/8-second off pattern and last approximately 3 minutes 9 seconds. Two 600-pulse blocks will be delivered per day, separated by a 15-minute interval, for a total of 1,200 pulses per day. Treatment will be administered on five consecutive weekdays, giving 10 stimulation blocks in total. | Device | active iTBS |
| Sham Intermittent Theta-Burst StimulationIn both groups, the TMS coil will be positioned over the primary motor cortex representation of the more affected lower limb and sham electrodes will be attached to the forehead. During sham stimulation, surface electrodes placed on the forehead will deliver low-intensity electrical stimulation at 2 mA to reproduce the somatosensory experience of TMS. The TMS device will simultaneously produce the characteristic clicking sound of coil discharge. The software will conceal the assigned mode from the participant and stimulation operator. The visit schedule, positioning, and total procedural duration will match the active condition. | Device | sham iTBS |
Primary outcome
The Modified Tardieu Scale Quality of Muscle Reaction Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
The entire more affected lower limb will be examined using the Modified Tardieu Scale. At baseline, the muscle group corresponding to the dominant spastic pattern will be predefined as the individual target muscle group and the same muscle group will be reassessed at all subsequent visits. The quality of muscle reaction at fast stretch velocity V3 is scored from 0 to 5, where 0 indicates no resistance and higher scores indicate a more pronounced catch or clonus; a lower score indicates less spasticity.
Worst Lower-Limb Pain Intensity on the Numeric Rating Scale
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Participants will rate the worst pain intensity experienced in the affected lower limb during the preceding 14 days on an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain.
12 secondary outcomes
Neuropathic Pain Features Measured by the Douleur Neuropathique 4 Questionnaire
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Impact Scale - Physical Impact Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Impact Scale - Psychological Impact Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Quality of Life-54 - Physical Health Composite Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Quality of Life-54 - Mental Health Composite Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Fatigue Scale for Motor and Cognitive Functions Total Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Hospital Anxiety and Depression Scale - Anxiety Subscale Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Hospital Anxiety and Depression Scale - Depression Subscale Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Multiple Sclerosis Neuropsychological Screening Questionnaire Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Patient-Determined Disease Steps Score
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
H/M Ratio as a Neurophysiological Marker of Spinal Excitability
Time frame: Baseline, Week 2, and Week 4 after the final stimulation session
Treatment-Emergent Adverse Events
Time frame: From the first stimulation session through Week 4 after the final stimulation session
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 26 Aug 2026.
- 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.
Peter Valkovič, prof. MD PhD. principal investigator
Faculty of Medicine, Comenius University Bratislava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intermittent Theta-Burst Stimulation (iTBS) in people with Multiple Sclerosis and Muscle Spasticity, run by Comenius University at 1 site in Slovakia.
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 6 inclusion and 4 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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 Karolína Lisá, MD (+421 2 5954 2297, karolina.lisa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Modified Tardieu Scale Quality of Muscle Reaction Score (time frame: Baseline, Week 2, and Week 4 after the final stimulation session). 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 26 Aug 2026.