Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Motor evoked potentials
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Placebo motor cortex stimulation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Motor evoked potentials
时间窗: From enrollment to the end of follow up at 12 weeks
Motor evoked potentials will be recorded at the start and the end of each stimulation session.
Spasticity lower extremities
时间窗: From enrollment to the end of follow-up at 12 weeks
The Wartenberg pendulum is an objective test to assess the biomechanical properties of spasticity.The test consists of dropping the leg of a relaxed patient from a horizontal position and measuring oscillatory movements with a goniometer.
10-meter walking test
时间窗: From enrollment to the end of follow-up at 12 weeks
The 10-meter walk test (10MWT) is used to assess walking capabilities and walking speed in patients with gait impairments. Three trials will be recorded at the patient's fastest walking speed. The three trials are averaged and the gait speeds are documented in meters/second.
Global spasticity
时间窗: From enrollment to the end of follow-up at 12 weeks
Spasticity will be evaluated by using the modified Ashworth scale from 0 (no spasticity) to 4 (rigid extremities).
Nine-Hole Peg Test
时间窗: From enrollment to the end of follow-up at 12 weeks
The Nine-Hole Peg Test is used to measure manual dexterity in patients with various neurological diagnoses. It is described in the literature to explore upper extremity function. Patients are asked to take nine pegs (7 mm diameter, 32 mm length) from a container (square box measuring 100 x 100 x 10 mm), one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
Lower extremities kinematics
时间窗: From enrollment to the end of follow-up at 12 weeks
Movement kinematics will be extracted from recordings with 3D motion capture trackers that will record joint coordinates in time.
次要结局
- European myelopathy score(From enrollment to the end of follow-up at 12 weeks)
- Numeric scale rating for pain evaluation(From enrollment to the end of follow-up at 12 weeks)
研究者
Mark Züchner
Principal Investigator
Oslo University Hospital