NCT06464744

Efficacy of rTMS Treatment After Spinal Cord Injury

Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	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	Placebo stimulation using a placebo coil	The placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation.

Timeline

• Start date: 2024-01-15
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2024-06-18
• Last updated: 2024-06-18

Locations

1 site across 1 country: Norway