The Effects of rTMS in Rehabilitation Following Spinal Cord Injury
Primary Purpose
Spinal Cord Injury, Rehabilitation, Transcranial Magnetic Stimulation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
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
Sites / Locations
- Spinal Cord Injury Centre of Western Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active rTMS
Sham rTMS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
6 minutes walking test
Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.
Lower limb maximal muscle strength
Measures the maximal voluntary contraction torque of the knee flexors and knee extensors.
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.
Rate of force development
Measures the explosive muscle force of the knee flexors and knee extensors.
10 meter walking test
Measures the time (in seconds) it takes to cover 10 meters during level-ground walking.
Secondary Outcome Measures
Quantitative Sensory Testing
Measures the sensitivity to heat and cold stimuli on the skin.
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.
Modified Ashworth Scale
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
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
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
A test for the pressure sensitivity of the pain nerve fibers in and superficial to the masseter and soleus muscles.
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".
Full Information
NCT ID
NCT03690726
First Posted
September 20, 2018
Last Updated
December 28, 2020
Sponsor
Spinal Cord Injury Centre of Western Denmark
Collaborators
University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03690726
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spinal Cord Injury Centre of Western Denmark
Collaborators
University of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Rehabilitation, Transcranial Magnetic Stimulation, Neurorehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Placebo Controlled Clinical Intervention Study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training
Intervention Type
Other
Intervention Name(s)
Sham stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
6 minutes walking test
Description
Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Lower limb maximal muscle strength
Description
Measures the maximal voluntary contraction torque of the knee flexors and knee extensors.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Timed up and go test
Description
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.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Rate of force development
Description
Measures the explosive muscle force of the knee flexors and knee extensors.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
10 meter walking test
Description
Measures the time (in seconds) it takes to cover 10 meters during level-ground walking.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Secondary Outcome Measure Information:
Title
Quantitative Sensory Testing
Description
Measures the sensitivity to heat and cold stimuli on the skin.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
H-reflex test
Description
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.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Modified Ashworth Scale
Description
A manual test that measures spasticity from 0 to 4, where 0 is no spasticity and 4 is widespread spasticity.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
The International Standards for Neurological Classification of Spinal Cord Injury
Description
An examination that is used to score the motor and sensory impairment and severity of a spinal cord injury.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Walking Index for Spinal Cord Injury test
Description
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.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Pressure algometry
Description
A test for the pressure sensitivity of the pain nerve fibers in and superficial to the masseter and soleus muscles.
Time Frame
Measures the change from baseline and after 8 weeks of intervention
Title
Self-reported pain
Description
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".
Time Frame
Measures the change from baseline and after 8 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge Kasch, MD, PhD
Organizational Affiliation
Spinal Cord Injury Centre of Western Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spinal Cord Injury Centre of Western Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of rTMS in Rehabilitation Following Spinal Cord Injury
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