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

NCT ID: NCT06593184

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Sequelae Gait Disorders, Neurologic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active trans-spinal magnetic stimulation

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

Group Type EXPERIMENTAL

Trans-spinal magnetic stimulation

Intervention Type DEVICE

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

Sham trans-spinal magnetic stimulation

Treadmill training with masking for trans-spinal magnetic stimulation

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type DEVICE

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

Interventions

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Trans-spinal magnetic stimulation

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

Intervention Type DEVICE

Sham Comparator

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

Intervention Type DEVICE

Other Intervention Names

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tsMS, transcutaneous spinal cord magnetic stimulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Paraiba

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Site Status RECRUITING

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Daniel G Melo, Physical Therapy

Role: CONTACT

55 + 81995173332

Facility Contacts

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Mayza Felix

Role: primary

+55 81 99207653

Daniel G Melo

Role: primary

+55 81 995173332

Ana P Fontana

Role: primary

+55 21 997651800

Other Identifiers

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tsMS_Stroke_Gait

Identifier Type: -

Identifier Source: org_study_id

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