The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690726
• Other study ID #: VCR-rTMS
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2020
• Source: Spinal Cord Injury Centre of Western Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurorehabilitation
• Rehabilitation
• Spinal Cord Injuries
• Spinal Cord Injury
• Transcranial Magnetic Stimulation
• Wounds and Injuries

Intervention

Device:
• repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training

Other:
• Sham 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

Locations

Country	Name	City	State
Denmark	Spinal Cord Injury Centre of Western Denmark	Viborg

Sponsors (2)

Lead Sponsor	Collaborator
Spinal Cord Injury Centre of Western Denmark	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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