The aim of this study is to evaluate the effects of tsDCS combined with physical therapy on the recovery of motor function in adult patients with chronic incomplete spinal cord injury.
A randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions). Active or sham tsDCS will be combined with physical therapy to verify the improvement of motor function in patients with incomplete spinal cord injury. Assessments will be performed before and after therapeutic sessions and at the 30-day follow-up after the intervention, through: (i) ASIA Lower and Upper Extremities Motor Scale (LEMS and UEMS), (ii) ASIA Impairment Scale (AIS), (iii) Ashworth Modified Scale; (iv) the Functional Independence Measure (SCIM-III), and (v) the Patient Global Impression of Change Scale - (PGICS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Patients with a neurological level above T10 will receive cervical tsDCS (anode electrode at C7, and the cathode electrode on the right shoulder). Patients with a neurological level from T10 onwards will receive thoracic tsDCS (anode electrode at T10, and the cathode electrode at the iliac crest). (i) Experimental group (active tsDCS): electrical stimulator (Neuroconn/Germany) connected to a pair of saline-soaked sponge electrodes (35 cm²) with a current intensity of 2.5 mA for 20 minutes. (ii) Control group (sham tsDCS) with electrodes positioned at the same locations as active tsDCS, for 30 seconds (the setup will remain for the full 20 minutes). Thus, patients will experience the initial sensations at the stimulated site, without inducing an effect. Physical therapy will be performed during tsDCS (45 minutes), based on scientific evidence, considering patient preferences, and respecting motor learning theory and neuroplasticity principles, focusing on motor function recovery.
Applied Neuroscience Laboratory
Recife, Pernambuco, Brazil
Changes in the Upper and Lower Extremities Motor Scale (UEMS and LEMS) from ASIA.
It is an international scale. The UEMS and LEMS are composed of the sum of muscle function grading for the five key muscles of the upper and lower limbs (respectively) as defined by ASIA. The score for each muscle is graded from '0' to '5', and the total score can range from '0' to '50'. To calculate this, the scores for the five muscles of each limb (upper and lower/ left and right) should be summed. The higher the score, the better the motor function.
Time frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Changes on American Spinal Cord Injury Association - Impairment Scale (AIS)
This is international scale, it is the gold standard for the diagnosis of spinal cord injury and is used worldwide. The AIS categorizes the lesion from full spinal cord injury to normal degree (severity of the injury), according to sensory-motor preservation, passing through degrees of spinal cord injury (A , B, C, D or E). (i) AIS A (Complete): no motor or sensory function preserved in the sacral regions (S4-S5); (ii) AIS B (Sensory incomplete): sensory function, but not motor, preserved below the neurological level; (iii) AIS C (Motor incomplete): motor function preserved, with more than half of the muscles scoring less than 3; (vi) AIS D (Motor incomplete): motor function preserved, with more than half of the muscles scoring 3 or more; and (v) AIS E (Normal): normal motor and sensory function. Observations: "AIS A" represents the worse outcome regarding the severity of the injury, and "AIS E" represents the better.
Time frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)
The scale assesses patients' ability to perform tasks inherent to spinal cord injury and detects improvements in their functionality. The SCIM-III is a scale from 0 to 100 points and divides into three main domains: self-care (feeding, bathing, dressing and cleanliness), breathing, sphincter control and mobility (indoors and out home and transfers). Higher scores on the SCIM III reflect higher levels of independence.
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Time frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Change from Modified Ashworth scale (MAS)
The Modified Ashworth Scale is a clinical measure for assessing muscle tone during passive movement with speed dependence and shows good validity and reproducibility. In this study, it will assess the following muscles: hip flexors and extensors, knee flexors and extensors, ankle dorsiflexors and plantar flexors; shoulder flexors and extensors, elbow flexors and extensors, wrist flexors and extensors. The instrument categorizes spasticity into six different grades, ranging from "0" (normal muscle tone) to "4" (joint rigidity in flexion or extension). The lower the score, the less spasticity assessed.
Time frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Changes on Patient Global Impression of Change Scale - (PGICS)
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better". This scale has already been validated in Brazil and has been used in clinical practice assays with spinal cord injury.
Time frame: After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.