Efficacy of rTMS Treatment After Spinal Cord Injury

University of Oslo (UIO)

Status: Enrolling

Conditions: Spinal Cord Injuries; Myelopathy

Treatments: Procedure: Placebo stimulation using a placebo coil; Procedure: Repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06464744

635283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Placebo stimulation

Placebo Comparator group

Description:

Patients will receive stimulation from a placebo coil that only delivers skin tingling but no active brain stimulation.

Treatment:

Procedure: Placebo stimulation using a placebo coil

Active stimulation

Active Comparator group

Description:

Patients will receive active brain stimulation from a magnetic figure-of-eight-coil.

Treatment:

Procedure: Repetitive transcranial magnetic stimulation (rTMS)