Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients

June 18, 2025 updated by: Kátia Monte-Silva, Universidade Federal de Pernambuco

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 23510-220
        • Recruiting
        • Federal University of Rio de Janeiro
        • Contact:
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58051-900
        • Recruiting
        • Federal University of Paraíba
        • Contact:
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-420
        • Recruiting
        • Federal University of Pernambuco
        • Contact:
        • Sub-Investigator:
          • Daniel G Melo, Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active trans-spinal magnetic stimulation
Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.
Device: Trans-spinal magnetic stimulation
Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.
Other Names:
  • tsMS, transcutaneous spinal cord magnetic stimulation
Sham Comparator: Sham trans-spinal magnetic stimulation
Treadmill training with masking for trans-spinal magnetic stimulation
Device: Sham Comparator
Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independency level
Time Frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
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).
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
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).
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
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.
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)
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.
End of treatment (2 weeks)
Spasticity
Time Frame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
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.
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
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.
Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tsMS_Stroke_Gait

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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