The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Transcranial Magnetic Stimulation; Rehabilitation; Spinal Cord Injury; Neurorehabilitation
• Intervention / Treatment: Device: repetitive transcranial magnetic stimulation; Other: Sham stimulation

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Spinal Cord Injury Centre of Western Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rTMS; 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; Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training
Sham Comparator: Sham rTMS; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spinal Cord Injury Centre of Western Denmark
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Helge Kasch, MD, PhD, Spinal Cord Injury Centre of Western Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: VCR-rTMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No