Feasibility Study to Investigate the Effects of Transcranial Magnetic Stimulation (TMS) Using Theta Burst Stimulation (TBS) to Treat Upper Limb Dysfunction and Spasticity in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility Criteria 1: Number of participants recruited
研究概览
简要总结
This study will investigate how repetitive transcranial magnetic stimulation (TMS) using intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of this study will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years old inclusive
- •Traumatic and non-traumatic tetraplegic patient following chronic incomplete (AIS C or D) SCI injury (sustained at least three months ago)
- •Referred to the Sheffield Spinal Injuries Centre
- •Be able to provide written informed consent or verbal consent in the presence of an independent witness
- •Spasticity affecting upper limbs with a Modified Ashworth scale (MAS) 2 or above
- •Stable medical treatment for at least 1 week before and 1 week after TMS application
- •Stable medical condition
排除标准
- •Aged less than 18 years old
- •Lack the mental capacity to consent
- •Ventilated patients with sedation
- •Very acute (<3 months) SCI patients
- •Implanted electrical devices such as pacemakers, Concomitant neurological conditions, including any history of epilepsy
- •Significant joint-related limitation of passive range of movement
- •Unable to attend all TMS sessions
- •Pregnancy
- •Inability to tolerate TBS
- •Significant upper limb contractures
研究组 & 干预措施
Active iTBS
iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. The hand representation of the primary motor cortex will targeted using a circular coil held over the vertex of skull. Intensity will be set to 80% of Resting Motor Threshold (RMT), which will be determined visually by the lowest percentage of stimulator output which can cause upper limb motor twitch in at least 5 out of 10 attempts.
干预措施: Transcranial Magnetic Stimulation using iTBS Paradigm (Device)
Sham iTBS
Sham iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. Intensity will be set at 80% RMT. Circular coil will be held over vertex of skull but angled away to ensure no neural stimulation.
干预措施: Transcranial Magnetic Stimulation using iTBS Paradigm (Device)
结局指标
主要结局
Feasibility Criteria 1: Number of participants recruited
时间窗: Through to study completion, up to 6 months
Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)
Feasibility Criteria 2: Number of participants completing intervention protocol
时间窗: Through to study completion, up to 6 months
10 participants completing full intervention protocol
Feasibility Criteria 3: Number of Valid data sets
时间窗: Through to study completion, up to 6 months
10 complete valid data sets
Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
时间窗: Through to study completion, up to 6 months
No serious adverse events
次要结局
- Spinal Cord Independence Measure (SCIM) - Version 3(Baseline and 2 weeks)
- Range of Motion (RoM)(Baseline and 2 weeks)
- Leeds Arm Spasticity Impact Scale (LASIS)(Baseline and 2 weeks)
- Visual Analogue Scale (Spasticity) (VAS-S)(Baseline and 2 weeks)
- American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)(Baseline and 2 weeks)
- Modified Ashworth Scale (MAS)(Baseline and 2 weeks)
- Visual Analogue Scale (Pain) - (VAS-P)(Baseline and 2 weeks)