NCT02899637

Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

Effects of High-Frequency Transcranial Magnetic Stimulation on Functional Performance of Subjects With Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Active high-frequency Transcranial Magnetic Stimulation	Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week
DEVICE	Sham high-frequency Transcranial Magnetic Stimulation	Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-12-01
• Completion: 2017-05-01
• First posted: 2016-09-14
• Last updated: 2016-09-14

Locations

1 site across 1 country: Brazil