Clinical trial NCT06464744: Efficacy of rTMS Treatment After Spinal Cord Injury
Official title: Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Myelopathy
Keywords: rTMS
rehabilitation
spinal cord injury
motor cortex stimulation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active motor cortex stimulation
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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:

  * 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

Primary outcomes:
measure: Motor evoked potentials
timeFrame: From enrollment to the end of follow up at 12 weeks
measure: Global spasticity
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: Spasticity lower extremities
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: Nine-Hole Peg Test
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: 10-meter walking test
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: Lower extremities kinematics
timeFrame: From enrollment to the end of follow-up at 12 weeks
Secondary outcomes:
measure: Numeric scale rating for pain evaluation
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: European myelopathy score
timeFrame: From enrollment to the end of follow-up at 12 weeks
Other outcomes:
measure: Potential adverse effect
timeFrame: From enrollment to the end of follow-up at 12 weeks
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Bjørn Atle Bjørnbeth, MD,PhD
role: STUDY_CHAIR
References: