Efficacy of rTMS Treatment After Spinal Cord Injury

Oslo University Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Motor evoked potentials

Motor evoked potentials will be recorded at the start and the end of each stimulation session.

Time frame: 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).