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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial

Authors: Amanda Vitória Lacerda de Araújo, Valéria Ribeiro Nogueira Barbosa, Gilma Serra Galdino, Felipe Fregni, Thais Massetti, Sara Lynn Fontes, Danilo de Oliveira Silva, Talita Dias da Silva, Carlos Bandeira de Mello Monteiro, James Tonks, Fernando Henrique Magalhães

Published in: Trials | Issue 1/2017

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Abstract

Background

Repetitive transcranial magnetic stimulation (rTMS) has been investigated as a new tool in neurological rehabilitation of individuals with spinal cord injury (SCI). However, due to the inconsistent results regarding the effects of rTMS in people with SCI, a randomized controlled double-blind crossover trial is needed to clarify the clinical utility and to assess the effect size of rTMS intervention in this population. Therefore, this paper describes a study protocol designed to investigate whether the use of rTMS can improve the motor and sensory function, as well as reduce spasticity in patients with incomplete SCI.

Methods

A double-blind randomized sham-controlled crossover trial will be performed by enrolling 20 individuals with incomplete SCI. Patients who are at least six months post incomplete SCI (aged 18–60 years) will be recruited through referral by medical practitioners or therapists. Individuals will be randomly assigned to either group 1 or group 2 in a 1:1 ratio, with ten individuals in each group. The rTMS protocol will include ten sessions of high-frequency rTMS (5 Hz) over the bilateral lower-limb motor area positioned at the vertex (Cz). Clinical evaluations will be performed at baseline and after rTMS active and sham.

Discussion

rTMS has produced positive results in treating individuals with physical impairments; thus, it might be promising in the SCI population. The results of this study may provide new insights to motor rehabilitation thereby contributing towards the better usage of rTMS in the SCI population.

Trial registration

ClinicalTrials.gov, NCT02899637. Registered on 25 August 2016.
Appendix
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Metadata
Title
Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial
Authors
Amanda Vitória Lacerda de Araújo
Valéria Ribeiro Nogueira Barbosa
Gilma Serra Galdino
Felipe Fregni
Thais Massetti
Sara Lynn Fontes
Danilo de Oliveira Silva
Talita Dias da Silva
Carlos Bandeira de Mello Monteiro
James Tonks
Fernando Henrique Magalhães
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2280-1

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