Stroke SequelaeNCT06593184
Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients
A study testing Trans-spinal magnetic stimulation in people with Stroke Sequelae and Gait Disorders, Neurologic, run by Universidade Federal de Pernambuco at 3 sites in Brazil.
Trial summary
The goal of this clinical trial is to learn if trans-spinal magnetic stimulation works to treat gait disorders in chronic stroke adults. It will also learn about the safety of trans-spinal magnetic stimulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke Sequelae, Gait Disorders, Neurologic, Stroke
- What is being tested?
- Trans-spinal magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 Jun 2024to 1 Aug 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of Stroke by digital or physical imaging or medical report
- Gait impairment
- Stroke with at least 6 months after ictus
Who cannot join
- Metallic implants in spinal cord
- Major orthopedic/rheumatological disorders
- Incapacity of verbal or non-verbal communication
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil3 sites, 3 recruiting
- Recruiting
Federal University of Paraiba
João Pessoa, Paraíba, 58051-900
Mayza Felix, +55 81 99207653, mayzaleite@gmail.com
- Recruiting
Federal University of Pernambuco
Recife, Pernambuco, 50670-420
Daniel G Melo, +55 81 995173332, gmelodaniel@gmail.com
Daniel G Melo, Physical Therapy
- Recruiting
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 23510-220
Ana P Fontana, +55 21 997651800, fontanaap@gmail.com
About this study
The goal of this clinical trial is to learn if trans-spinal magnetic stimulation works to treat gait disorders in chronic stroke adults. It will also learn about the safety of trans-spinal magnetic stimulation.
The main questions it aims to answer are:
Read more
Does trans-spinal magnetic stimulation enhance chronic stroke participants gait and functional mobility? Does the technique cause any side effects?
Researchers will compare trans-spinal magnetic stimulation to a sham (a look-alike stimulation with no real effect) to see if trans-spinal magnetic stimulation works to treat gait disorders and improve functional mobility.
Participants will:
Receive trans-spinal magnetic stimulation with treadmill training or a sham stimulation with treadmill training every day for 2 weeks.
- Conditions
- Stroke Sequelae, Gait Disorders, Neurologic, Stroke
- Being tested
- Trans-spinal magnetic stimulation, Sham Comparator
- Keywords
- Spinal cord, Magnetic Stimulation, Trans-spinal magnetic stimulation, Stroke
- Medical subject headings
- Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-spinal magnetic stimulationDevice
Also called tsMS, transcutaneous spinal cord magnetic stimulation
Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.
Sham ComparatorDevice
Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered
| Study group | Role | What they receive |
|---|---|---|
| Active trans-spinal magnetic stimulation | Experimental | Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability. Receives: Device: Trans-spinal magnetic stimulation |
| Sham trans-spinal magnetic stimulation | Sham comparator | Treadmill training with masking for trans-spinal magnetic stimulation Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Mobility
The Timed-Up and Go (TUG) test is used to evaluate an individual´s capacity to stand up, walk, and sit down. During the test, the participants are timed from the moment they begin to stand up until they are seated again.
Measured: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Secondary outcomes (6)
Independency level
Self-reported independence is assessed using the Functional Ambulation Categories (FAC). Scores range from 0 (inability to walk even with external help) to 5 (normal ambulation).
Measured: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Lower limb motor function
Motor function of the lower limbs is assessed using the Fugl-Meyer Assessment, where scores range from 0 (indicating the worst motor function) to 28 (indicating normal motor function).
Measured: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Balance
Capacity to maintain balance during various tasks is assessed using the Mini Balance Evaluation System (MiniBEST-test). Its scores range from 0 to 28 points. Lower scores indicate poor balance, while higher scores reflect better balance.
Measured: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Perceived change in treatment
Evaluation of how the participant describes the perceived change in their condition since the treatment started, using the Patient Global Impression of Change (PGM). This scale assesses the change in activity limitations, symptoms, emotions, and overall quality of life since the beginning of treatment, ranging from no change or worsening to significant improvement that made a considerable difference. A score of one indicates no change, while a score of seven represents a substantial improvement.
Measured: End of treatment (2 weeks)
Spasticity
Tonus disorders will be assessed using the Modified Ashworth Scale, which measures spasticity by grading muscle resistance during passive stretching. The scale ranges from 0 to 4, where 0 indicates no increase in muscle tone, and 4 represents a limb that is rigid in flexion or extension.
Measured: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Sensory Function
Assessed using a method inspired by the ASIA scale, evaluating the lower thoracic, mid-thoracic, and lower cervical dermatomes, where a score of 0 indicates absence of sensitivity and 2 indicates normal sensitivity.
Measured: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Randomized controlled clinical trial, double blinded (therapist/evaluator, patient) Initial evaluation, followed by 10 days of treatment, followed by a re-evaluation immediately after and follow-up 30 days after finishing.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593184
- Sponsor's protocol ID
- tsMS_Stroke_Gait
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06593184
- Acronym / sponsor ID
- tsMS_Stroke_Gait
- Conditions
- Stroke Sequelae, Gait Disorders, Neurologic, Stroke
- Keywords
- Spinal cord, Magnetic Stimulation, Trans-spinal magnetic stimulation, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this clinical trial is to learn if trans-spinal magnetic stimulation works to treat gait disorders in chronic stroke adults. It will also learn about the safety of trans-spinal magnetic stimulation.
The main questions it aims to answer are:
Does trans-spinal magnetic stimulation enhance chronic stroke participants gait and functional mobility? Does the technique cause any side effects?
Researchers will compare trans-spinal magnetic stimulation to a sham (a look-alike stimulation with no real effect) to see if trans-spinal magnetic stimulation works to treat gait disorders and improve functional mobility.
Participants will:
Receive trans-spinal magnetic stimulation with treadmill training or a sham stimulation with treadmill training every day for 2 weeks.
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
- Randomized controlled clinical trial, double blinded (therapist/evaluator, patient) Initial evaluation, followed by 10 days of treatment, followed by a re-evaluation immediately after and follow-up 30 days after finishing.
| Arm | Type | Receives |
|---|---|---|
| Active trans-spinal magnetic stimulation | Experimental | Device: Trans-spinal magnetic stimulationTrans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability. |
| Sham trans-spinal magnetic stimulation | Sham comparator | Device: Sham ComparatorTreadmill training with masking for trans-spinal magnetic stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmation of Stroke by digital or physical imaging or medical report
- Gait impairment
- Stroke with at least 6 months after ictus
Key exclusion criteria (3 listed)
- Metallic implants in spinal cord
- Major orthopedic/rheumatological disorders
- Incapacity of verbal or non-verbal communication
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 |
|---|---|---|
| Trans-spinal magnetic stimulationAlso: tsMS, transcutaneous spinal cord magnetic stimulationTrans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability. | Device | Active trans-spinal magnetic stimulation |
| Sham ComparatorSham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered | Device | Sham trans-spinal magnetic stimulation |
Primary outcome
Functional Mobility
Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
The Timed-Up and Go (TUG) test is used to evaluate an individual´s capacity to stand up, walk, and sit down. During the test, the participants are timed from the moment they begin to stand up until they are seated again.
6 secondary outcomes
Independency level
Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Lower limb motor function
Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Balance
Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Perceived change in treatment
Time frame: End of treatment (2 weeks)
Spasticity
Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Sensory Function
Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
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 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-spinal magnetic stimulation in people with Stroke Sequelae and Gait Disorders, Neurologic, run by Universidade Federal de Pernambuco at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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 Daniel G Melo, Physical Therapy (55 + 81995173332, gmelodaniel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Mobility (time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment). 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 24 Jun 2025.