Spinal Cord InjuryNCT03690726
The Effects of rTMS in Rehabilitation Following Spinal Cord Injury
A study testing repetitive transcranial magnetic stimulation in people with Spinal Cord Injury and Rehabilitation, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Rehabilitation, Transcranial Magnetic Stimulation
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jan 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sub-acute (<6 months) incomplete spinal cord injury
- admitted at the SCIWDK for primary rehabilitation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spinal Cord Injury, Rehabilitation, Transcranial Magnetic Stimulation, Neurorehabilitation
- Being tested
- repetitive transcranial magnetic stimulation, Sham stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training
Sham stimulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | 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. Receives: Device: repetitive transcranial magnetic stimulation |
| Sham rTMS | Sham comparator | 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. Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test
Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measures the change from baseline and after 8 weeks of intervention
Secondary outcomes (7)
Quantitative Sensory Testing
Measures the sensitivity to heat and cold stimuli on the skin.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Measures the change from baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start2 Jan 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Placebo Controlled Clinical Intervention Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Cord Injury Centre of Western Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Helge Kasch, Spinal Cord Injury Centre of Western Denmark
- Investigators
- Helge Kasch, MD, PhD, Principal investigator, Spinal Cord Injury Centre of Western Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690726
- Sponsor's protocol ID
- VCR-rTMS
- Status last verified
- Dec 2020
- First submitted
- 20 Sep 2018
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03690726
- Acronym / sponsor ID
- VCR-rTMS
- Conditions
- Spinal Cord Injury, Rehabilitation, Transcranial Magnetic Stimulation, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Spinal Cord Injury Centre of Western DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Placebo Controlled Clinical Intervention Study
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: repetitive transcranial magnetic stimulationSCI 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. |
| Sham rTMS | Sham comparator | Other: Sham stimulationSCI 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sub-acute (<6 months) incomplete spinal cord injury
- admitted at the SCIWDK for primary rehabilitation
Key exclusion criteria (7 listed)
- Medical history of multiple central nervous system lesions,
- severe structural,
- inflammatory or degenerative cerebral disorders,
- epilepsy,
- other neurological diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationRepetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training | Device | Active rTMS |
| Sham stimulationImitated 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 | Other | Sham rTMS |
Primary outcome
6 minutes walking test
Time frame: Measures the change from baseline and after 8 weeks of intervention
Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.
Lower limb maximal muscle strength
Time frame: Measures the change from baseline and after 8 weeks of intervention
Measures the maximal voluntary contraction torque of the knee flexors and knee extensors.
Timed up and go test
Time frame: 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
Time frame: Measures the change from baseline and after 8 weeks of intervention
Measures the explosive muscle force of the knee flexors and knee extensors.
10 meter walking test
Time frame: 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.
7 secondary outcomes
Quantitative Sensory Testing
Time frame: Measures the change from baseline and after 8 weeks of intervention
H-reflex test
Time frame: Measures the change from baseline and after 8 weeks of intervention
Modified Ashworth Scale
Time frame: Measures the change from baseline and after 8 weeks of intervention
The International Standards for Neurological Classification of Spinal Cord Injury
Time frame: Measures the change from baseline and after 8 weeks of intervention
Walking Index for Spinal Cord Injury test
Time frame: Measures the change from baseline and after 8 weeks of intervention
Pressure algometry
Time frame: Measures the change from baseline and after 8 weeks of intervention
Self-reported pain
Time frame: Measures the change from baseline and after 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Kasch, MD, PhD principal investigator
Spinal Cord Injury Centre of Western Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Spinal Cord Injury and Rehabilitation, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (time frame: Measures the change from baseline and after 8 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.