The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Systematic, Repetitive Transcranial Magnetic Stimulation in Rehabilitation After Incomplete Spinal Cord Injury: Neuromuscular Adaptations and Recovery of Lower Limb Muscle Strength

Conditions
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Spinal Cord Injury, Rehabilitation, Transcranial Magnetic Stimulation, Neurorehabilitation

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation
* Other: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sub-acute (<6 months) incomplete spinal cord injury admitted at the SCIWDK for primary rehabilitation Exclusion Criteria: Medical history of multiple central nervous system lesions, severe structural, inflammatory or degenerative cerebral disorders, epilepsy, other neurological diseases, lower limb peripheral injury, or orthopedic injuries that may limit maximal effort contractions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Interventional Model Description: Randomized Placebo Controlled Clinical Intervention Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS<br>SCI patients fulfilling criteria for participation giving informed written and verbal consent, who are enrolled and randomised to active treatment arm receive consecutive treatment sessions with rTMS directed at cranium and cortex regions as described in protocol. | Device: repetitive transcranial magnetic stimulation<br>* Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training<br>|
| Sham Comparator: Sham rTMS<br>SCI patients fulfilling criteria for participation giving informed written and verbal consent, who are enrolled and randomised to sham/control arm receive consecutive treatment sessions with coil from rTMS that fires at other spot (pillow/mattress) as described in protocol. | Other: Sham stimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walking test | Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes. | 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. | 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. | 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. | 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. | Measures the change from baseline and after 8 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Sensory Testing | Measures the sensitivity to heat and cold stimuli on the skin. | 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. | 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. | 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. | 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. | 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. | 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. | Measures the change from baseline and after 8 weeks of intervention |