Efficacy of rTMS Treatment After Spinal Cord Injury

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Motor evoked potentials [Срок оценки: From enrollment to the end of follow up at 12 weeks]
• Global spasticity [Срок оценки: From enrollment to the end of follow-up at 12 weeks]
• Spasticity lower extremities [Срок оценки: From enrollment to the end of follow-up at 12 weeks]
• Nine-Hole Peg Test [Срок оценки: From enrollment to the end of follow-up at 12 weeks]
• 10-meter walking test [Срок оценки: From enrollment to the end of follow-up at 12 weeks]
• Lower extremities kinematics [Срок оценки: From enrollment to the end of follow-up at 12 weeks]

Вторичные конечные точки (2)

• Numeric scale rating for pain evaluation [Срок оценки: From enrollment to the end of follow-up at 12 weeks]
• European myelopathy score [Срок оценки: From enrollment to the end of follow-up at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Oslo University Hospital - Rikshospitalet — Oslo

Идентификаторы

NCT: NCT06464744 · 635283

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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