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

NCT06593184 | Recruiting

• 1 other identifier: tsMS_Stroke_Gait
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Stroke Sequelae; Gait Disorders, Neurologic; Stroke

Keywords

Spinal cord; Magnetic Stimulation; Trans-spinal magnetic stimulation; Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

Secondary Outcomes (6)

• Independency level

  Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

• Lower limb motor function

  Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

• Balance

  Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

• Perceived change in treatment

  End of treatment (2 weeks)

• Spasticity

  Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment

Study Arms (2)

Active trans-spinal magnetic stimulation

EXPERIMENTAL

Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.

Device: Trans-spinal magnetic stimulation

Sham trans-spinal magnetic stimulation

SHAM COMPARATOR

Treadmill training with masking for trans-spinal magnetic stimulation

Device: Sham Comparator

Interventions

Trans-spinal magnetic stimulation DEVICE

Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.

Also known as: tsMS, transcutaneous spinal cord magnetic stimulation

Active trans-spinal magnetic stimulation

Sham Comparator DEVICE

Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered

Sham trans-spinal magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmation of Stroke by digital or physical imaging or medical report
• Gait impairment
• Stroke with at least 6 months after ictus

You may not qualify if:

• Metallic implants in spinal cord
• Major orthopedic/rheumatological disorders
• Incapacity of verbal or non-verbal communication

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (3)

Federal University of Paraiba

João Pessoa, Paraíba, 58051-900, Brazil

RECRUITING

Federal University of Pernambuco

Recife, Pernambuco, 50670-420, Brazil

RECRUITING

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 23510-220, Brazil

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Daniel G Melo, Physical Therapy

CONTACT

55 + 81995173332; gmelodaniel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

BR (3)