Spinal Cord InjuriesNCT06464744
Efficacy of rTMS Treatment After Spinal Cord Injury
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Spinal Cord Injuries and Myelopathy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
There is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation (rTMS) of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Myelopathy
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2024to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years and less than 80 years
- Chronic patients with an incomplete cervical and/or thoracic spinal cord injury (traumatic and non-traumatic) affecting upper and/or lower extremities (i.e., C4-T12 and classified as ASIA C or D) (Figure 138).
- Capable and willing to provide informed consent and able to adhere to the treatment schedule
- Patients who can be followed for the whole duration of the study
- 6.3 Exclusion criteria
- Contraindication to rTMS:
Show all 21Show fewer
- past severe head trauma
- history of epilepsy or ongoing epilepsy
- active cerebral tumor
- intracranial hypertension
- implanted ferromagnetic devices such as cardiac pacemaker and neurostimulator and cochlear implants
- pregnancy or lactation.
- Any clinically significant or unstable medical or psychiatric disorder
- Other ongoing research protocol or recent past protocol within two months before the inclusion
- History of treatment with Deep Brain Stimulation (DBS)
- Subjects protected by law (guardianship or tutelage measure)
- History of substance abuse (alcohol, drugs)
- Pending litigation
- Impossibility to understand the protocol or to fill out the forms
- Chronic use of sedative medication
- Participation in another clinical trial evaluating spinal cord injury
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital - Rikshospitalet
Oslo, Norway, 0372
Mark Züchner, MD, PhD, +4723070000, mark.zuchner@medisin.uio.no
Jean-Luc Boulland, Assoc. Prof., +4722851081, j.l.boulland@medisin.uio.no
About this study
Official title: Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
There is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation (rTMS) of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury. This study is designed to assess the clinical potential of non-invasive stimulation of the primary motor cortex to improve motor functions.The results will help to evaluate the clinical relevance of motor cortex stimulation for motor functions in patients with spinal cord injury. The outcomes of this study could potentially support the initiation of a larger clinical trial and the development of a new routine treatment.
Read the detailed description
The investigators will recruit 20 patients with low cervical or thoracic ASIA C or D spinal cord injuries based on specific inclusion and exclusion criteria. The patients will be randomized into 2 groups. Each group will receive either the theta burst stimulation or the placebo stimulation. rTMS will be delivered using a figure-of-eight coil positioned on the patient's head, targeting the leg area of the primary motor cortex. After the motor threshold (MT) is determined patients will receive a unilateral 90% subthreshold theta burst stimulation for 3 minutes The protocol includes 15 stimulation sessions over a 3-week period. The 12-week follow up consist of a series of electrophysiological and functional tests to assess upper and lower limb function bilaterally. Secondary outcomes include pain using the NRS scale, and self-reported evaluation of autonomic functions before, during, and after the treatment.
- Conditions
- Spinal Cord Injuries, Myelopathy
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Placebo stimulation using a placebo coil
- Keywords
- rTMS, rehabilitation, spinal cord injury, motor cortex stimulation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Procedure or surgery
Intermittent Theta burst stimulation will be delivered on the on the primary motor cortex using a figure-of-eight coil, supported by neuronavigation. The stimulation intensity will be set to 90% of the motor threshold
Placebo stimulation using a placebo coilProcedure or surgery
The placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Placebo stimulation | Placebo comparator | Patients will receive stimulation from a placebo coil that only delivers skin tingling but no active brain stimulation. Receives: Procedure: Placebo stimulation using a placebo coil |
| Active stimulation | Active comparator | Patients will receive active brain stimulation from a magnetic figure-of-eight-coil. Receives: Procedure: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potentials
Motor evoked potentials will be recorded at the start and the end of each stimulation session.
Measured: From enrollment to the end of follow up at 12 weeks
Global spasticity
Spasticity will be evaluated by using the modified Ashworth scale from 0 (no spasticity) to 4 (rigid extremities).
Measured: From enrollment to the end of follow-up at 12 weeks
Spasticity lower extremities
The Wartenberg pendulum is an objective test to assess the biomechanical properties of spasticity.The test consists of dropping the leg of a relaxed patient from a horizontal position and measuring oscillatory movements with a goniometer.
Measured: From enrollment to the end of follow-up at 12 weeks
Nine-Hole Peg Test
The Nine-Hole Peg Test is used to measure manual dexterity in patients with various neurological diagnoses. It is described in the literature to explore upper extremity function. Patients are asked to take nine pegs (7 mm diameter, 32 mm length) from a container (square box measuring 100 x 100 x 10 mm), one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
Measured: From enrollment to the end of follow-up at 12 weeks
10-meter walking test
The 10-meter walk test (10MWT) is used to assess walking capabilities and walking speed in patients with gait impairments. Three trials will be recorded at the patient's fastest walking speed. The three trials are averaged and the gait speeds are documented in meters/second.
Measured: From enrollment to the end of follow-up at 12 weeks
Lower extremities kinematics
Movement kinematics will be extracted from recordings with 3D motion capture trackers that will record joint coordinates in time.
Measured: From enrollment to the end of follow-up at 12 weeks
Secondary outcomes (2)
Numeric scale rating for pain evaluation
The analgesic efficacy of the stimulation protocol will be measured by the numeric scale rating (NRS), a self-reported measure in which patients rate their pain on a scale from 0 (no pain) to 10 (worst pain).
Measured: From enrollment to the end of follow-up at 12 weeks
European myelopathy score
The European myelopathy score is a reliable tool to assess functional recovery. The score ranges from 5 to 18. Higher values indicate better neurological function (outcome).
Measured: From enrollment to the end of follow-up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start15 Jan 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Active motor cortex stimulation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Züchner, Oslo University Hospital
- Investigators
- Bjørn Atle Bjørnbeth, MD,PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464744
- Sponsor's protocol ID
- 635283
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2024
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06464744
- Acronym / sponsor ID
- 635283
- Conditions
- Spinal Cord Injuries, Myelopathy
- Keywords
- rTMS, rehabilitation, spinal cord injury, motor cortex stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 18 Jun 2024 (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.
There is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation (rTMS) of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury. This study is designed to assess the clinical potential of non-invasive stimulation of the primary motor cortex to improve motor functions.The results will help to evaluate the clinical relevance of motor cortex stimulation for motor functions in patients with spinal cord injury. The outcomes of this study could potentially support the initiation of a larger clinical trial and the development of a new routine treatment.
Detailed description
The investigators will recruit 20 patients with low cervical or thoracic ASIA C or D spinal cord injuries based on specific inclusion and exclusion criteria. The patients will be randomized into 2 groups. Each group will receive either the theta burst stimulation or the placebo stimulation. rTMS will be delivered using a figure-of-eight coil positioned on the patient's head, targeting the leg area of the primary motor cortex. After the motor threshold (MT) is determined patients will receive a unilateral 90% subthreshold theta burst stimulation for 3 minutes The protocol includes 15 stimulation sessions over a 3-week period. The 12-week follow up consist of a series of electrophysiological and functional tests to assess upper and lower limb function bilaterally. Secondary outcomes include pain using the NRS scale, and self-reported evaluation of autonomic functions before, during, and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Active motor cortex stimulation
| Arm | Type | Receives |
|---|---|---|
| Placebo stimulation | Placebo comparator | Procedure: Placebo stimulation using a placebo coilPatients will receive stimulation from a placebo coil that only delivers skin tingling but no active brain stimulation. |
| Active stimulation | Active comparator | Procedure: Repetitive transcranial magnetic stimulation (rTMS)Patients will receive active brain stimulation from a magnetic figure-of-eight-coil. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age over 18 years and less than 80 years
- Chronic patients with an incomplete cervical and/or thoracic spinal cord injury (traumatic and non-traumatic) affecting upper and/or lower extremities (i.e., C4-T12 and classified as ASIA C or D) (Figure 138).
- Capable and willing to provide informed consent and able to adhere to the treatment schedule
- Patients who can be followed for the whole duration of the study
- 6.3 Exclusion criteria
Key exclusion criteria (0 listed)
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 stimulation (rTMS)Intermittent Theta burst stimulation will be delivered on the on the primary motor cortex using a figure-of-eight coil, supported by neuronavigation. The stimulation intensity will be set to 90% of the motor threshold | Procedure or surgery | Active stimulation |
| Placebo stimulation using a placebo coilThe placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation. | Procedure or surgery | Placebo stimulation |
Primary outcome
Motor evoked potentials
Time frame: From enrollment to the end of follow up at 12 weeks
Motor evoked potentials will be recorded at the start and the end of each stimulation session.
Global spasticity
Time frame: From enrollment to the end of follow-up at 12 weeks
Spasticity will be evaluated by using the modified Ashworth scale from 0 (no spasticity) to 4 (rigid extremities).
Spasticity lower extremities
Time frame: From enrollment to the end of follow-up at 12 weeks
The Wartenberg pendulum is an objective test to assess the biomechanical properties of spasticity.The test consists of dropping the leg of a relaxed patient from a horizontal position and measuring oscillatory movements with a goniometer.
Nine-Hole Peg Test
Time frame: From enrollment to the end of follow-up at 12 weeks
The Nine-Hole Peg Test is used to measure manual dexterity in patients with various neurological diagnoses. It is described in the literature to explore upper extremity function. Patients are asked to take nine pegs (7 mm diameter, 32 mm length) from a container (square box measuring 100 x 100 x 10 mm), one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
10-meter walking test
Time frame: From enrollment to the end of follow-up at 12 weeks
The 10-meter walk test (10MWT) is used to assess walking capabilities and walking speed in patients with gait impairments. Three trials will be recorded at the patient's fastest walking speed. The three trials are averaged and the gait speeds are documented in meters/second.
Lower extremities kinematics
Time frame: From enrollment to the end of follow-up at 12 weeks
Movement kinematics will be extracted from recordings with 3D motion capture trackers that will record joint coordinates in time.
2 secondary outcomes
Numeric scale rating for pain evaluation
Time frame: From enrollment to the end of follow-up at 12 weeks
European myelopathy score
Time frame: From enrollment to the end of follow-up at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
Bjørn Atle Bjørnbeth, MD,PhD study chair
Oslo University Hospital
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 (rTMS) in people with Spinal Cord Injuries and Myelopathy, run by Oslo University Hospital at 1 site in Norway.
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 21 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Züchner, MD, PhD (+47 23070000, mark.zuchner@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potentials (time frame: From enrollment to the end of follow up at 12 weeks). The study lists 6 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 28 Oct 2026.