Efficacy of rTMS Treatment After Spinal Cord Injury
NCT Number: NCT06464744
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries|Myelopathy
Interventions: PROCEDURE: Repetitive transcranial magnetic stimulation (rTMS)|PROCEDURE: Placebo stimulation using a placebo coil
Sponsor: Oslo University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2029-09
Locations: Oslo University Hospital - Rikshospitalet, Oslo, 0372, Norway

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. 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.

Primary Outcome Measures: 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, 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
Secondary Outcome Measures: 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, 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
Other Outcome Measures: 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:

* Displacement of ferromagnetic device
* Headache (3% in conventional rTMS studies) because of the noise generated by the stimulation
* Seizures (0,16% in conventional rTMS studies) particularly in those with past epilepsy or brain surgery
* Application site pain or discomfort and jaw pain, From enrollment to the end of follow-up at 12 weeks