Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are:
- is starting electrical stimulation 3 days post SCI safe?
- can starting electrical stimulation 3 days post SCI help patients recover movement?
This study will be done in two phases. Both phases will be done during the patient's stay in the hospital/intensive care unit (ICU).
In the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury.
- assessment of the ability to move arms/legs and feel touch or pin prick
- blood and cerebral spinal fluid draws
- assessment of their spinal cord function using electrical stimulation
- receive a single 60-minute continuous electrical stimulation treatment
- patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.
In the second phase, researchers will compare active electrical stimulation to sham stimulation to see if active stimulation safely leads to improvement in person's movement ability.
In this second phase, participants' will undergo tests before and after electrical stimulation treatment which will be delivered 5 days in the row. Assessments will be repeated before the patient will go home at around 7 days post injury.
- assessment of the ability to move arms/legs (every day) and feel touch or pin prick (before and after 5 days of treatment)
- blood and cerebral spinal fluid draws (before the first treatment session and before going home)
- assessment of their spinal cord function using electrical stimulation (before the first treatment session and before going home)
- receive daily 60-minute continuous electrical stimulation treatment for 5 days while in ICU
- patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.
详细描述
Spinal cord injury (SCI) is often devastating, as many SCI patients are permanently disabled resulting in decades of lost productivity and quality adjusted life years. Patients must largely rely on supportive care, as no Federal Drug Administration (FDA)- approved therapy to treat aSCI exists. Even with early aggressive physical therapy, voluntary movement below the level of the lesion is limited or even absent. There is critical unmet need for strategies to preserve neural function and prevent the host of complications in the hyperacute phase after SCI until discharge to acute rehabilitation.
In the proposed project, Safety of Transcutaneous Electrical stimulation Potentiating Recovery in Acute spinal cord Injury SyndromEs (STEP-RAISE), we will conduct a combined Phase 1 and Phase 2 pilot clinical trial of non-invasive transcutaneous spinal cord stimulation (tSCS), and track the course of neurophysiological recovery following aSCI with granular objective outcome measures to determine whether implementation of early tSCS below the level of lesion can safely augment the functional recovery.
Specific Aims:
Aim 1: Test the safety of tSCS applied below the level of injury to the lumbosacral spinal cord after acute spinal cord injury, starting 72 hours after injury. We hypothesize that there will be no adverse events associated with acute application of tSCS. To assess safety, we will quantify the impacts of tSCS on hemodynamics, spinal cord perfusion pressure (SCPP), and monitor for local skin site reactions.
Aim 2: Demonstrate the proof-of-principle that tSCS application in the acute phase post-injury can potentiate recovery. We hypothesize that tSCS can improve volitional movement and/or sensation acutely after SCI as measured by an improved American Spinal Injury Association Impairment Score (ASIA) score in the presence of tSCS.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject will be eligible for enrollment in the study of the following criteria apply:
- •Written informed consent is obtained.
- •Acute traumatic cervicothoracic SCI that meets all of the following criteria:
- •Acute SCI presenting to the hospital within 12 hours of injury
- •Traumatic non-penetrating SCI
- •American Impairment Scale (AIS) Grade A, B, or C
- •International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10
- •Aged >/=18 years
- •Admission to Intensive Care Unite (ICU) with lumbar drain in place per standard of care
排除标准
- •A subject will not be eligible for this study if ANY of the following criteria apply:
- •Subjects classified as AIS D or E
- •Penetrating SCIs or complete transection of the spinal cord
- •Incarceration or police custody
- •Class 2 or Class 3 obesity
- •Any concomitant injury that, in the judgment of the Investigator, interferes with the procedures and examinations required by the study protocol, including but not limited to:
- •multiple spinal cord lesions
- •fractures requiring lower extremity casts or splints
- •skin breakdown or burns over the lumbar spine
- •profound hemodynamic instability
- •traumatic brain injury (defined by Glasgow Coma Scale (GCS) <14 at enrollment or inability to participate in exam)
研究组 & 干预措施
sham_tSCS
sham treatment
干预措施: sham transcutaneous spinal cord stimulation (Device)
active_tSCS
active treatment
干预措施: transcutaneous spinal cord stimulation (Device)
结局指标
主要结局
Incidence of adverse events
时间窗: From enrollment to the end of treatment at 7 days post injury
Number of observed events over the transcutaneous spinal cord stimulation (tSCS) sessions. Examples of adverse events (AE) that will be carefully monitored * Hemodynamic instability * Skin irritation * Patient condition deterioration * Unanticipated AE
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores
时间窗: From enrollment to the end of study at 6 months follow up
International Standards for Neurological Classification of SCI (ISNCSCI) motor scores; Standardized manual muscle testing is used to assess the strength of each key muscle, typically on a 6-point scale (0-5, 0 - total paralysis to 5 - normal strength with full ROM against gravity and maximal resistance); The motor score is derived by summing the individual muscle grades, with a maximum score of 50 for each upper and lower extremity, and a total maximum score of 100 for both limbs. Immediate change in scores with acute tSCS and change in scores from baseline to post treatment and at 6-month follow up will be assessed in the study.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores
时间窗: From enrollment to the end of study at 6 months follow up
International Standards for Neurological Classification of SCI (ISNCSCI) sensory scores on a 3-point scale to assess sensory function in each dermatome: 0 for absent sensation, 1 for impaired/altered sensation, and 2 for normal sensation. This scoring is done for both light touch and pinprick sensation in each of the 28 dermatomes bilaterally, resulting in a maximum possible score of 112 for each sensation. The sensory level is determined by the most caudal dermatome where sensation is intact for both light touch and pinprick, according to the American Spinal Injury Association. Immediate change in scores from baseline vs acute tSCS, post treatment and at 6-months follow up will be assessed.
Motor evoked potentials (MEPs)
时间窗: From enrollment to post treatment at 7 days post injury
Single pulse, monophasic spinal cord stimulation will be used to evoke motor potentials. Surface electromyography (EMG) electrodes will be placed on the leg Rectus Femoris (RF), Biceps Femoris (BF), Medial Gastrocnemius (MG) and Tibialis Anterior (TA) muscles, where MEPs will be measured from. The data collected will be assessed for MEP presence/elicited (binary measure) and the number of muscles with elicitable MEPs at baseline vs post treatment.
Electromyography (EMG)
时间窗: From enrollment to study completion at 6 months follow up
Eight surface electromyography recording electrodes, placed bilaterally over the lower extremity muscles: Rectus Femoris (RF), Biceps Femoris (BF), Medial Gastrocnemius (MG) and Tibialis Anterior (TA) will be used to record motor output (EMG activity) during ISNCSCI assessment. Changes in EMG amplitude in the presence of tSCS vs no tSCS (within subject); changes in the number of muscles with EMG output in the presence of tSCS vs no tSCS (within subject) will be analyzed.
次要结局
- Quality of Life in Neurological Disorders (Neuro-QoL) scores(At 6-months follow up)
- Spinal Cord Independence Measure scores(At 6-month follow up)
- Incidence of neuropathic pain at 6-month follow-up(From enrollment to study completion at 6-months follow up)
- Pain Intensity(From enrollment to 6-month follow up)
- Electromyography (EMG)(From enrollment to study completion at 6 months follow up)
- Motor evoked potentials (MEPs)(From enrollment to post treatment at 7 days post injury)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores(From enrollment to the end of study at 6 months follow up)
- Concentration of neuronal (UCH-L1) and glial cell (GFAP) injury markers in blood(From enrollment to the end of treatment at 7 days post SCI)
- Cerebrospinal fluid (CSF) proteomics(From enrollment to the end of treatment at 7 days post SCI)
- Incidence of neuropathic pain at 6-month follow-up(From enrollment to study completion at 6-months follow up)
- Pain Intensity(From enrollment to 6-month follow up)
- Quality of Life in Neurological Disorders (Neuro-QoL) scores(At 6-months follow up)
- Spinal Cord Independence Measure scores(At 6-month follow up)