Neurorehabilitation, Rehabilitation, Spinal Cord Injury, Transcranial Magnetic Stimulation
Conditions
Brief summary
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.
Interventions
DEVICErepetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training
OTHERSham stimulation
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
Sponsors
University of Southern Denmark
Spinal Cord Injury Centre of Western Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized Placebo Controlled Clinical Intervention Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 minutes walking test | Measures the change from baseline and after 8 weeks of intervention | Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes. |
| Lower limb maximal muscle strength | Measures the change from baseline and after 8 weeks of intervention | Measures the maximal voluntary contraction torque of the knee flexors and knee extensors. |
| Timed up and go test | Measures the change from baseline and after 8 weeks of intervention | 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. |
| Rate of force development | Measures the change from baseline and after 8 weeks of intervention | Measures the explosive muscle force of the knee flexors and knee extensors. |
| 10 meter walking test | Measures the change from baseline and after 8 weeks of intervention | Measures the time (in seconds) it takes to cover 10 meters during level-ground walking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Sensory Testing | Measures the change from baseline and after 8 weeks of intervention | Measures the sensitivity to heat and cold stimuli on the skin. |
| H-reflex test | Measures the change from baseline and after 8 weeks of intervention | 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. |
| Modified Ashworth Scale | Measures the change from baseline and after 8 weeks of intervention | A manual test that measures spasticity from 0 to 4, where 0 is no spasticity and 4 is widespread spasticity. |
| The International Standards for Neurological Classification of Spinal Cord Injury | Measures the change from baseline and after 8 weeks of intervention | An examination that is used to score the motor and sensory impairment and severity of a spinal cord injury. |
| Walking Index for Spinal Cord Injury test | Measures the change from baseline and after 8 weeks of intervention | 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. |
| Pressure algometry | Measures the change from baseline and after 8 weeks of intervention | A test for the pressure sensitivity of the pain nerve fibers in and superficial to the masseter and soleus muscles. |
| Self-reported pain | Measures the change from baseline and after 8 weeks of intervention | 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. |
Countries
Denmark
Outcome results
None listed