Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial
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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-11-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2280-1 |
| _version_ | 1811274141594025984 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Amanda Vitória Lacerda de Araújo |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T23:13:46Z |
| format | Article |
| id | doaj.art-30b1acfaed7a4e4b9d9eb4882b9b67c6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T23:13:46Z |
| publishDate | 2017-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-30b1acfaed7a4e4b9d9eb4882b9b67c62022-12-22T03:12:44ZengBMCTrials1745-62152017-11-0118111110.1186/s13063-017-2280-1Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trialAmanda Vitória Lacerda de Araújo0Valéria Ribeiro Nogueira Barbosa1Gilma Serra Galdino2Felipe Fregni3Thais Massetti4Sara Lynn Fontes5Danilo de Oliveira Silva6Talita Dias da Silva7Carlos Bandeira de Mello Monteiro8James Tonks9Fernando Henrique Magalhães10School of Arts, Sciences and Humanities, EACH – USP, University of São PauloDepartment of Physiotherapy – UEPB, Paraíba State UniversityDepartment of Physiotherapy – UEPB, Paraíba State UniversityHarvard Center for Noninvasive Brain Stimulation, Harvard Medical SchoolSchool of Arts, Sciences and Humanities, EACH – USP, University of São PauloFaculty of Medicine, University of British ColumbiaPhysical Therapy Program – UNESP, State University of São PauloSchool of Arts, Sciences and Humanities, EACH – USP, University of São PauloSchool of Arts, Sciences and Humanities, EACH – USP, University of São PauloUniversity of Exeter Medical SchoolSchool of Arts, Sciences and Humanities, EACH – USP, University of São PauloAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2280-1Incomplete spinal cord injuryPlasticityMotor rehabilitationNon-invasive brain stimulationRepetitive transcranial magnetic stimulation |
| spellingShingle | 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 Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial Trials Incomplete spinal cord injury Plasticity Motor rehabilitation Non-invasive brain stimulation Repetitive transcranial magnetic stimulation |
| 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 |
| title_full | Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial |
| title_fullStr | Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial |
| title_full_unstemmed | Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial |
| title_short | Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial |
| title_sort | effects of high frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury study protocol for a randomized controlled trial |
| topic | Incomplete spinal cord injury Plasticity Motor rehabilitation Non-invasive brain stimulation Repetitive transcranial magnetic stimulation |
| url | http://link.springer.com/article/10.1186/s13063-017-2280-1 |
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