A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in nine-hole peg test
研究概览
简要总结
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •Male or Female subjects
- •At least 18 years old and no older than 70 years old at the time of enrollment.
- •Able-bodied subjects
- •Traumatic spinal cord injury
- •Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
- •Lower limb target: neurological level at or above Thoracic 10 level, with residual lower limb function; AIS B, C or D impairment grade primary could ambulate;
- •Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairment grade, primary wheelchair user
- •Spinal cord injury sustained more than 6 months prior to study.
- •Movement/excitability/etc:
- •Upper limb target: Has detectable residual connection in upper-limb muscles in at least one side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) and a visible contraction when functional electrical stimulation (FES) is applied in the hand or wrist muscle at baseline.
- •Lower limb target: Has detectable residual connection in lower-limb muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in lower limb ankle plantar or dorsiflexor muscle at baseline.
- •Trunk target: Has detectable residual connection in trunk muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in trunk muscle at baseline.
- •Able to commit to intervention and assessment sessions over a maximum duration of 2 months.
排除标准
- •Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
- •Has severe spasticity that could prevent the study protocol as determined by the investigator.
- •Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
- •Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.
- •Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS.
- •Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols.
- •Has a history of epilepsy, convulsion or seizures.
- •Individuals with metal implants in their head or spine near the sites to be stimulated and other implantable devices (e.g., cochlear implants) in the body that could be affected by TMS or TSCS.
- •Has implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation or VNS).
- •Has a cardiac pacemaker or intracardiac lines.
- •Has peripheral neuropathy, including diabetic polyneuropathy and entrapment neuropathy.
- •Has urinary tract infection, unhealed fracture, contracture, and pressure sore as determined by Braden Scale value of 14 and below.
- •Individuals who require therapy or other care that could interfere with participation in the study.
- •Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
- •Individuals with substance disorders, including alcoholism and drug abuse.
- •Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
- •In the opinion of the investigators, the study is not safe or appropriate for the participant.
结局指标
主要结局
Change in nine-hole peg test
时间窗: baseline, up to 2 months
The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the activity, recorded in seconds.
Change in Function in Sitting Test for people with SCI (FIST-SCI)
时间窗: baseline, up to 2 months
FIST-SCI is a clinical test that will be used to test seated balance. FIST-SCI consists of 14 functional, everyday activities as test items. The items are scored on a 5 point ordinal scale ranging from 0 to 4, with 0 representing the lowest ability and 4 representing normal ability.
Change in foot tapping test (FTT)
时间窗: baseline, up to 2 months
FTT assesses motor neuron function and mobility. Participants are seated with the foot on the floor and are asked to tap their foot on the ground as rapidly as possible for 10 seconds while keeping the heel on the ground. The number of taps are counted during the 10 seconds.
Change in Motor Evoked Potential (MEP)
时间窗: baseline, up to 2 months
MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
次要结局
未报告次要终点
研究者
Matija Milosevic
Assistant Professor
University of Miami