Efficacy of rTMS Treatment After Spinal Cord Injury

Last updated: June 17, 2024
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Disorders

Spinal Cord Injuries

Spinal Stenosis

Treatment

Repetitive transcranial magnetic stimulation (rTMS)

Placebo stimulation using a placebo coil

Clinical Study ID

NCT06464744
635283
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Repetitive transcranial magnetic stimulation (rTMS)
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
September 30, 2029

Study 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.

Connect with a study center

  • Oslo University Hospital - Rikshospitalet

    Oslo, 0372
    Norway

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.