The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

Not Applicable

Completed

• Conditions: Rehabilitation; Neurorehabilitation; Spinal Cord Injury; Transcranial Magnetic Stimulation
• Interventions: Other: Sham stimulation; Device: repetitive transcranial magnetic stimulation

• Registration Number: NCT03690726
• Lead Sponsor: Spinal Cord Injury Centre of Western Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2019-01-02
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	Sham stimulation	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.
Active rTMS	repetitive transcranial magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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".

Trial Locations

Locations (1)

Spinal Cord Injury Centre of Western Denmark; 🇩🇰 Viborg, Denmark