The project will investigate whether repetitive transcranial magnetic stimulation (rTMS) can be used to potentiate/prime spinal cord injured patients' nervous systems for more intense rehabilitation exercise of longer duration - thus leading to greater recovery of motion function. The technique, in which a magnetic coil is positioned above the scalp and forms a magnetic field that activates the desired center of the brain (eg motor cortex), is used in clinical practice for the treatment of a number of disorders. However, although a combination of rTMS and gait training in SCI patients previously has proven beneficial, it is unknown whether additional functional gains can be achieved by combining rTMS and supervised, high-intensity resistance training. In this project, 30 newly-admitted patients will be recruited and randomized to receive either active rTMS and strength training (n = 15) or sham (imitated) rTMS + strength training, in parallel with standard care. The investigators hypothesize that the active rTMS group will have superior gains in locomotor function and muscle mass, compared to the sham group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training
Imitated magnetic stimulation: An active coil will be activated under the subject's head, firing down into the mattress, while an inactive coil will be held over the scalp
Spinal Cord Injury Centre of Western Denmark
Viborg, Denmark
6 minutes walking test
Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Lower limb maximal muscle strength
Measures the maximal voluntary contraction torque of the knee flexors and knee extensors.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Timed up and go test
Measures the time (in seconds) it takes a person to get up from an ordinary chair with back and armrest, walk 3 meters, turn back to the chair and sit back.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Rate of force development
Measures the explosive muscle force of the knee flexors and knee extensors.
Time frame: Measures the change from baseline and after 8 weeks of intervention
10 meter walking test
Measures the time (in seconds) it takes to cover 10 meters during level-ground walking.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Quantitative Sensory Testing
Measures the sensitivity to heat and cold stimuli on the skin.
Time frame: Measures the change from baseline and after 8 weeks of intervention
H-reflex test
Measures spasticity from the ratio of the amplitude between the M-wave and H-wave. These are evoked during a short electrical stimulation impulse delivered to the nerves innervating the soleus muscle.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Modified Ashworth Scale
A manual test that measures spasticity from 0 to 4, where 0 is no spasticity and 4 is widespread spasticity.
Time frame: Measures the change from baseline and after 8 weeks of intervention
The International Standards for Neurological Classification of Spinal Cord Injury
An examination that is used to score the motor and sensory impairment and severity of a spinal cord injury.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Walking Index for Spinal Cord Injury test
A test that assesses the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Pressure algometry
A test for the pressure sensitivity of the pain nerve fibers in and superficial to the masseter and soleus muscles.
Time frame: Measures the change from baseline and after 8 weeks of intervention
Self-reported pain
Examines self-reported pain through a 100mm Visual-Analogue Scale, scored 0-100, where 0 is "no pain" and 100 is "the greatest pain imaginable".
Time frame: Measures the change from baseline and after 8 weeks of intervention
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