Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

University of Sao Paulo

Status: Unknown

Conditions: Spinal Cord Injury

Treatments: Device: Sham high-frequency Transcranial Magnetic Stimulation; Device: Active high-frequency Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02899637

18753713.0.0000.5187

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Spinal Cord Injury (Active Group)

Experimental group

Description:

Active high-frequency Transcranial Magnetic Stimulation

Treatment:

Device: Active high-frequency Transcranial Magnetic Stimulation

Spinal Cord Injury (Control group)

Sham Comparator group

Description:

Sham high-frequency Transcranial Magnetic Stimulation

Treatment:

Device: Sham high-frequency Transcranial Magnetic Stimulation