Neuromodulation to Improve Grasping Function After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Motor evoked potential (MEP)
研究概览
简要总结
The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if we can increase inputs to late descending signals above the level of injury and to increase output of residual late descending signals below the level of injury. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.
详细描述
We will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, we will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, we will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. We will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, we propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For individuals with SCI:
- •Ages 18-75 years
- •Chronic SCI (≥1 year of injury)
- •Cervical injury at C8 or above
- •Individuals who have MEP responses in at least one FDI muscle
排除标准
- •Uncontrolled medical problems including pulmonary or cardiovascular disease
- •Premorbid, ongoing major depression or psychosis, altered cognitive status
- •History of head injury or stroke
- •Metal plate in skull
- •History of seizures
- •Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs
- •Pregnant females
- •Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical
研究组 & 干预措施
iTBS and PCMS
iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
干预措施: iTBS (Other)
iTBS and PCMS
iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
干预措施: PCMS (Other)
Sham iTBS and PCMS
Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
干预措施: Sham iTBS (Other)
Sham iTBS and PCMS
Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
干预措施: PCMS (Other)
iTBS and PCMS with exercise
Participants will complete iTBS and PCMS with exercise for 10 sessions.
干预措施: iTBS (Other)
iTBS and PCMS with exercise
Participants will complete iTBS and PCMS with exercise for 10 sessions.
干预措施: PCMS (Other)
iTBS and PCMS with exercise
Participants will complete iTBS and PCMS with exercise for 10 sessions.
干预措施: Exercise (Behavioral)
Sham iTBS and sham PCMS with exercise
Participants will complete sham stimulation with exercise for 10 sessions.
干预措施: Sham iTBS (Other)
Sham iTBS and sham PCMS with exercise
Participants will complete sham stimulation with exercise for 10 sessions.
干预措施: Sham PCMS (Other)
结局指标
主要结局
Motor evoked potential (MEP)
时间窗: For the first study, the time frame will be one day, before and after each session. For the second study, the time frame will be 3 weeks, before and after 10 sessions.
Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.
次要结局
- Maximum voluntary contraction (MVC)(For the first study, the time frame will be one day, before and after each session. For the second study, the time frame will be 3 weeks, before and after 10 sessions.)
- Grip force(For the first study, the time frame will be one day, before and after each session. For the second study, the time frame will be 3 weeks, before and after 10 sessions.)
- Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)(For the first study, the time frame will be one day, before and after each session. For the second study, the time frame will be 3 weeks, before and after 10 sessions.)
研究者
Hang Jin Jo
Assistant Professor
State University of New York at Buffalo