Clinical trial NCT03690726: The Effects of rTMS in Rehabilitation Following Spinal Cord Injury
Official title: The Effects of Systematic, Repetitive Transcranial Magnetic Stimulation in Rehabilitation After Incomplete Spinal Cord Injury: Neuromuscular Adaptations and Recovery of Lower Limb Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Rehabilitation
Transcranial Magnetic Stimulation
Neurorehabilitation
Lead sponsor: Spinal Cord Injury Centre of Western Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2018-10-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Placebo Controlled Clinical Intervention Study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6 minutes walking test
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Lower limb maximal muscle strength
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Timed up and go test
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Rate of force development
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: 10 meter walking test
timeFrame: Measures the change from baseline and after 8 weeks of intervention
Secondary outcomes:
measure: Quantitative Sensory Testing
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: H-reflex test
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Modified Ashworth Scale
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: The International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Walking Index for Spinal Cord Injury test
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Pressure algometry
timeFrame: Measures the change from baseline and after 8 weeks of intervention
measure: Self-reported pain
timeFrame: Measures the change from baseline and after 8 weeks of intervention
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Spinal Cord Injury Centre of Western Denmark
Study officials:
affiliation: Spinal Cord Injury Centre of Western Denmark
name: Helge Kasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: