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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo stimulation | Placebo Comparator | Patients will receive stimulation from a placebo coil that only delivers skin tingling but no active brain stimulation. |
|
| Active stimulation | Active Comparator | Patients will receive active brain stimulation from a magnetic figure-of-eight-coil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Motor evoked potentials | Motor evoked potentials will be recorded at the start and the end of each stimulation session. | 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). | 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. | 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. | 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. | From enrollment to the end of follow-up at 12 weeks |
| Lower extremities kinematics |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of follow-up at 12 weeks |
| European myelopathy score |
| Measure | Description | Time Frame |
|---|---|---|
| Potential adverse effect | In general, rTMS is a safe method. The use of exclusion criteria and ear plugs during stimulation will reduce side effects. Potential risks or side effects of rTMS include:
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Inclusion Criteria:
6.3 Exclusion criteria
Contraindication to rTMS:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Züchner, MD, PhD | Contact | +47 23070000 | mark.zuchner@medisin.uio.no |
| Name | Affiliation | Role |
|---|---|---|
| Bjørn Atle Bjørnbeth, MD,PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital - Rikshospitalet | Recruiting | Oslo | 0372 | Norway |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Active motor cortex stimulation
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Placebo motor cortex stimulation
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| Placebo stimulation using a placebo coil | Procedure | The placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation. |
|
Movement kinematics will be extracted from recordings with 3D motion capture trackers that will record joint coordinates in time. |
| From enrollment to the end of follow-up at 12 weeks |
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). |
| From enrollment to the end of follow-up at 12 weeks |
| From enrollment to the end of follow-up at 12 weeks |