Clinical trial NCT02899637: Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury
Official title: Effects of High-Frequency Transcranial Magnetic Stimulation on Functional Performance of Subjects With Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Incomplete Spinal Cord Injury
Rehabilitation
Non-invasive brain stimulation
Transcranial Magnetic Stimulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Estadual da Paraiba
First posted: 2016-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective is to conduct a study protocol to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of patients with iSCI will be conducted.

Detailed description: Effective rehabilitation programs for individuals with incomplete spinal cord injury (iSCI) are required either in the acute or in the post-acute care. Rehabilitation techniques based on protocols that selectively stimulate specific pathways along the central nervous system have been considered effective in enhancing neurologic recovery thereby improving functional abilities. The rationale relies on the assumption that the stimulation of the corticospinal tract, primary motor cortex, and spinal cord might induce neuronal reorganization of structures that are largely involved in the control of voluntary movements. In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic transmission, attenuating neuropathic pain, improving spasticity and sensorimotor function after iSCI. However, controversial findings have also been reported, as other studies showed unaltered central pain, as well as cortical excitability and sensorimotor function. The lack of consistent results is probably associated with differences in stimulation parameters, number of sessions, site of stimulation, chronicity and levels of injury, and outcome measurements of the previous studies. Thus, it is clear that there are remaining gaps in our knowledge and the development of new studies, preferably prospective fully double-blind placebo-controlled trials, is necessary to complement the current knowledge about the effects of rTMS in patients with iSCI.

Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of iSCI with nonprogressive etiology
* Clinical stability
* Aged between 18-60 years old
* Score equal to 24 in the Mini-Mental State Examination
* No electroencephalography alterations
* Absence of depression assessed by Hamilton Depression Scale
* Currently receiving inpatient rehabilitation in Physiotherapy Health Center of University of the State of Paraiba, Brazil.

Exclusion Criteria:

* Have metal prosthesis in some part of the body
* Use cardiac pacemaker
* Present dementia or neurological disorders which can increase cortical excitability
* Have psychotic or schizophrenic disorders
* Take drugs that reduce seizure threshold or spasticity.

Primary outcomes:
measure: American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks.
timeFrame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.
Secondary outcomes:
measure: American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score.
timeFrame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.
measure: Fugl-Meyer Scale for Upper and Lower Members, Assessment of change in motor scores from baseline to three weeks.
timeFrame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.
measure: Electromyography (lower limbs), Assessment of change in motor function from baseline to three weeks.
timeFrame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks.
Other outcomes:
Locations:
city: Campina Grande
country: Brazil
facility: Universidade Estadual da Paraiba
state: Paraiba
Study officials:
affiliation: University of Sao Paulo
name: Fernando H Magalhaes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belci M, Catley M, Husain M, Frankel HL, Davey NJ. Magnetic brain stimulation can improve clinical outcome in incomplete spinal cord injured patients. Spinal Cord. 2004 Jul;42(7):417-9. doi: 10.1038/sj.sc.3101613.
citation: Benito J, Kumru H, Murillo N, Costa U, Medina J, Tormos JM, Pascual-Leone A, Vidal J. Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):106-12. doi: 10.1310/sci1802-106.
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citation: Kang BS, Shin HI, Bang MS. Effect of repetitive transcranial magnetic stimulation over the hand motor cortical area on central pain after spinal cord injury. Arch Phys Med Rehabil. 2009 Oct;90(10):1766-71. doi: 10.1016/j.apmr.2009.04.008.
citation: Kumru H, Murillo N, Samso JV, Valls-Sole J, Edwards D, Pelayo R, Valero-Cabre A, Tormos JM, Pascual-Leone A. Reduction of spasticity with repetitive transcranial magnetic stimulation in patients with spinal cord injury. Neurorehabil Neural Repair. 2010 Jun;24(5):435-41. doi: 10.1177/1545968309356095. Epub 2010 Jan 6.
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citation: Tazoe T, Perez MA. Effects of repetitive transcranial magnetic stimulation on recovery of function after spinal cord injury. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S145-55. doi: 10.1016/j.apmr.2014.07.418. Epub 2014 Aug 29.
citation: Yilmaz B, Kesikburun S, Yasar E, Tan AK. The effect of repetitive transcranial magnetic stimulation on refractory neuropathic pain in spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):397-400. doi: 10.1179/2045772313Y.0000000172. Epub 2013 Nov 11.
citation: de Araujo AVL, Barbosa VRN, Galdino GS, Fregni F, Massetti T, Fontes SL, de Oliveira Silva D, da Silva TD, Monteiro CBM, Tonks J, Magalhaes FH. 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. 2017 Nov 6;18(1):522. doi: 10.1186/s13063-017-2280-1.