Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trans-spinal magnetic stimulation, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Stroke Sequelae, Gait Disorders, Neurologic, Stroke. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Trans-spinal magnetic stimulation
Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability. - Device Sham Comparator
Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered
Primary outcome measures
- Functional Mobility [Time frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- Confirmation of Stroke by digital or physical imaging or medical report
- Gait impairment
- Stroke with at least 6 months after ictus
Exclusion criteria
- Metallic implants in spinal cord
- Major orthopedic/rheumatological disorders
- Incapacity of verbal or non-verbal communication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Brazil · 3 centers
- Federal University of Paraiba — João Pessoa
- Federal University of Pernambuco — Recife
- Federal University of Rio de Janeiro — Rio de Janeiro
Identifiers
NCT: NCT06593184 · tsMS_Stroke_Gait