Characterization of Physiological Changes Induced Through Motor-evoked Potential Conditioning in People With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI)
研究概览
简要总结
The study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.
Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, the study team will use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.
Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurologically stable (>1 year post SCI)
- •Medical clearance to participate
- •Ability to ambulate at least 10 m with or without an assistive device (except for parallel bars)
- •Signs of weak ankle dorsiflexion at least unilaterally
- •Expectation that current medication will be maintained without change for at least 3 months; stable use of anti-spasticity medication is accepted
排除标准
- •motoneuron injury
- •known cardiac condition (e.g., history of myocardial infarction, congestive heart failure, pacemaker use)
- •medically unstable condition
- •cognitive impairment
- •history of epileptic seizures
- •metal implants in the cranium
- •implanted biomedical device in or above the ches (e.g., a cardiac pacemaker, cochlear implant)
- •no measurable MEP elicited
- •unable to produce any voluntary TA EMG activity
- •extensive use of functional electrical stimulation to the leg on a daily basis
- •pregnancy (due to changes in weight and posture and potential medical instability)
结局指标
主要结局
Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI)
时间窗: Baseline through 3 months post intervention
Decreased SICI indicates increased excitability in the brain
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Studied Leg
时间窗: Baseline through 3 months post intervention
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Studied Leg
时间窗: Baseline through 3 months post intervention
An increased maximum MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Change in ankle joint motion during walking (deg)--Studied Leg
时间窗: Baseline through 3 months post intervention
Ankle range of motion over the step cycle (in deg); Ankle peak flexion angle (in deg); Ankle angle at foot contact (in deg); Median ankle angle over the step cycle (in deg)
Change in walking speed (m/s) as measured by the 10-meter walk test
时间窗: Baseline through 3 months post intervention
Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Studied Leg
时间窗: Baseline through 3 months post intervention
Increased EMG amplitude indicates greater activation of the muscle, which could indicate an increased ability to lift the toes during the swing-phase of walking
Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Studied Leg
时间窗: Baseline through 3 months post intervention
Reorganization of the TA cortical map would suggest that operant conditioning of the muscle response changes the brain. Knowing if and how the brain changes will help investigators understand the potential impact of this type of training.
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Studied Leg
时间窗: Baseline through 3 months post intervention
An increase in the size of the CMEP (mV) elicited at a fixed stimulus intensity would indicate increased excitability/strength at the spinal cord level
Change in walking distance (meters) as measured by the 6-minute walk test
时间窗: Baseline through 3 months post intervention
The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.
Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Studied Leg
时间窗: Baseline through 3 months post intervention
Increased F-wave amplitude and/or occurrence indicates increased excitability/strength of the spinal cord-muscle pathway
次要结局
- Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Contralateral Leg(Baseline through 3 months post intervention)
- Change in ankle joint motion during walking (deg)--Studied Leg(Baseline through 3 months post intervention)
- Change in hip joint motion during walking (deg)--Both Legs(Baseline through 3 months post intervention)
- Changes in reflexes and muscle activation during walking as measured by H-reflex size and cutaneous reflex size(Baseline through 3 months post intervention)
- Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Contralateral Leg(Baseline through 3 months post intervention)
- Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Contralateral Leg(Baseline through 3 months post intervention)
- Change in knee joint motion during walking (deg)--Both Legs(Baseline through 3 months post intervention)
- Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Contralateral Leg(Baseline through 3 months post intervention)
- Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Contralateral Leg(Baseline through 3 months post intervention)
- Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Contralateral Leg(Baseline through 3 months post intervention)
研究者
Aiko Thompson
Associate Professor
Medical University of South Carolina