An interventional study of Active high-frequency Transcranial Magnetic Stimulation and Sham high-frequency Transcranial Magnetic Stimulation in Spinal Cord Injury, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Active high-frequency Transcranial Magnetic Stimulation
Device: Active high-frequency Transcranial Magnetic Stimulation
Sham high-frequency Transcranial Magnetic Stimulation
Device: Sham high-frequency Transcranial Magnetic Stimulation
Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week
Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Plan to share: No
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University of Sao Paulo