Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Active high-frequency Transcranial Magnetic Stimulation
* Device: Sham high-frequency Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Injury (Active Group)<br>Active high-frequency Transcranial Magnetic Stimulation | Device: Active high-frequency Transcranial Magnetic Stimulation<br>* Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week<br>|
| Sham Comparator: Spinal Cord Injury (Control group)<br>Sham high-frequency Transcranial Magnetic Stimulation | Device: Sham high-frequency Transcranial Magnetic Stimulation<br>* Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks. | The ASIA Motor Score is derived from part of the assessment for the International Standards for Neurological Classification of Spinal Cord Injury. It involves testing the strength of ten key muscles on each side of the body in the supine position (e.g., elbow flexors, wrist extensors, hip flexors, quadriceps, dorsiflexors) on a scale of 0 = no contraction to 5 = normal resistance through full range of motion. Scores are summed to give a total possible score of 50 for the upper extremities and 50 for the lower extremities. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score. | The ASIA Sensory score is also part of the assessment for the International Standard for Neurological Classification of Spinal Cord Injury. It involves testing pinprick and light touch sensation at key points representing each dermatome. Pin-prick and light-touch sensation of each dermatome is separately scored on a 3-point scale (0, 1 and 2). Scores will be summed to give a total possible score of 224 where a higher score indicates better sensation than a lower score. | 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. | 
| Fugl-Meyer Scale for Upper and Lower Members, Assessment of change in motor scores from baseline to three weeks. |  | 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. | 
| Electromyography (lower limbs), Assessment of change in motor function from baseline to three weeks. |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incomplete Spinal Cord Injury, Rehabilitation, Non-invasive brain stimulation, Transcranial Magnetic Stimulation