Spasticity After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- MEP recruitment curves
研究概览
简要总结
Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI.
详细描述
After spinal cord injury (SCI), damage to descending motor pathways has been associated with the development of spasticity (Frigon and Rossignol, 2006; Trompetto et al., 2014). Self-reported questionnaires and clinical exams indicate that individuals with incomplete SCI, who showed residual descending connectivity, have a high prevalence of spasticity compared to individuals with complete SCI (Little et al., 1989; Holtz et al., 2017). In agreement, our recent electrophysiological and spinal cord imaging data in humans with a diagnosis of a clinically motor complete SCI showed the presence of descending motor pathway connectivity in individuals with spasticity compared to those without spasticity (Sangari et al., 2019). However, which descending motor pathways influence spasticity following SCI, and to what extent, remains poorly understood. This proposal has two main goals: 1) to examine the contribution of cortico- and reticulo-spinal pathways to spasticity in upper and lower limb muscles, and 2) to develop strategies to promote functional recovery of upper and lower limb spastic muscles in humans with chronic incomplete SCI. The aims below will test two main hypotheses.
In Aim 1, we will use transcranial magnetic stimulation and startle acoustic stimuli to examine the contribution of the cortico- and reticulo-spinal pathway to upper and/or lower limb muscles electromyographic activity. Spinal cord atrophy and morphological characterization of cortico- and reticulo-spinal pathways will be assessed with high-resolution magnetic resonance imaging. Physiological and neuroimaging outcomes will be associated with clinical assessment of spasticity.
In Aim 2, we propose to enhance cortico- and reticulo-spinal contribution to upper and/or lower limb function in spastic muscles by using a novel intervention combining startle acoustic stimuli with motor training.
This research will provide new knowledge about the contribution of descending motor pathways to the control of spasticity in upper and lower limb muscles following incomplete cervical SCI (Aim1) and might lead to the development of a novel rehabilitation intervention to improve upper and lower limb motor function recovery by enhancing residual descending control over spinal networks (Aim 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Chronic SCI (≥1 year of injury)
- •Incomplete spinal cord injury at T12 or above
- •Males and Females
- •Ages 18-75 years
- •Inclusion criteria for non-spastic individuals with SCI
- •MAS scores of 0 and 1
- •Inclusion criteria for spastic individuals with SCI
- •MAS scores of 2, 3 and 4
- •The ability to perform a voluntary flexion and extension of the elbow and/or knee or ankle
- •The ability to reach and grasp an object
- •Inclusion criteria for health controls
- •Males and females
- •Ages 18-75 years
- •Right-handed
- •Able to perform elbow and/or knee or ankle flexion and extension
排除标准
- •for individuals with SCI and healthy controls:
- •Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
- •Any debilitating disease prior to the SCI that caused exercise intolerance
- •Premorbid, ongoing major depression or psychosis, altered cognitive status
- •History of head injury or stroke
- •Pacemaker
- •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 (chlorpromazine, clozapine) or tricyclic antidepressants
- •Pregnant females
- •Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk
研究组 & 干预措施
Aim 1
To accomplish this aim, we will conduct one experiment in two sessions separated by 2- 3 days using a crossover design. Participants will be assigned into one of three groups: spastic SCI, non-spastic SCI, and controls. We expect that people enrolled in Aim 1 will complete 2 visits within 1 week.
Visit 1 Measurements:
- MVCs
- MEP Recruitment Curves
- iMEPs
- StartReact
Visit 2 Measurements:
- Participant Reported Spasticity
- MAS
- PSAD
- KINARM
- MRI of brain and spinal cord
干预措施: Acoustic stimuli (Startle) (Behavioral)
Aim 2
To accomplish this aim, we will use a randomized crossover design study with spastic SCI participants receiving a single intervention combining non-invasive acoustic stimuli (Startle) or sham-Startle with motor training to enhance cortico- and reticulo-spinal contribution, separated by ~2 weeks.
Visit 1 and Visit 2
Single intervention of:
Startle + exercise training OR sham-Startle + exercise training
Pre and post measurements:
- MVCs
- MEP recruitment curves
- iMEPs
- StartReact
- Participant reported spasticity
- MAS
- PSAD
- KINARM
- Neuromechanical hand and/or leg testing
- GRASSP
- TRI-HFT
- 10-meter walk test
- Pendulum Test
干预措施: Acoustic stimuli (Startle) (Behavioral)
结局指标
主要结局
MEP recruitment curves
时间窗: 3-4 hours
Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).
Modified Ashworth Scale (MAS)
时间窗: 3-4 hours
This scale measures resistance encountered during manual passive muscle stretching using a six-point ordinal scale.
StartReact
时间窗: 3-4 hours
Here, participants will be asked to observe a light-emitting diode (LED) located in front of their head. When the LED will illuminate, individuals will be asked to move their arm or leg. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone.
Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)
时间窗: 3-4 hours
This exam measures gross motor function frequently used to manipulate objects that participants may encounter in their daily lives.
Participant reported spasticity
时间窗: 3-4 hours
Spasticity questionnaire
Pendulum Test
时间窗: 3-4 hours
As part of the physical exam, we will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.
Portable Spasticity Assessment Device (PSAD)'
时间窗: 3-4 hours
The PSAD combine biomechanical and electrophysiological measurements for an objective quantification of active and passive component of muscle stiffness
10-meter walk test
时间窗: 3-4 hours
10-meter walk test will be used to assess walking speed
Ipsilateral MEPs (iMEPs)
时间窗: 3-4 hours
Ten stimuli will be delivered during head straight and ten stimuli will be delivered during lateral head rotation, randomly alternated (0.2 Hz).
Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).
时间窗: 3-4 hours
This exam measures clinical impairment that incorporates three domains vital to upper-limb function: sensation, strength, and prehension.
次要结局
未报告次要终点
研究者
Monica Perez
Scientific Chair Arms + Hands Lab
Shirley Ryan AbilityLab