Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups:
- Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention.
- Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed.
- Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.
详细描述
Spinal cord injury (SCI) can result from primary physical insults such as acute trauma, or secondary insults that result from chronic compression and ischemia. The resultant neurological impairment leads to high personal and societal burden. There are few effective therapies to improve function for those living with SCI. Spinal cord stimulation (SCS) represents a safe and potentially effective treatment for persons with SCI-related pain and paralysis. The aim of this study is to investigate the potential clinical utility of SCS delivered transcutaneously in patients at various stages of SCI, resulting from traumatic and non-traumatic mechanisms. This study will evaluate the ability to safely stimulate the injured spinal cord at defined intervals and record autonomic and sensorimotor function of participants across their admission, rehabilitation, and clinical follow-up.
Various upper and lower extremity-related functional measures will be assessed at baseline and at established follow-up timepoints across a 12-month period. The safety of this intervention, and the utility of each outcome measure will be the primary outcome of the study. To our knowledge, there are no reported clinical trials that have evaluated multi-modal outcomes of SCS. Furthermore, there are no proposed trials of SCS for these SCI subtypes across the post-injury spectrum posted to the platform clinicaltrials.gov. Data obtained from this pilot evaluation will be used to inform an early phase Ib/II trial of efficacy for improvement of paralysis, autonomic dysfunction, and pain following SCI.
Over 2.5 million Americans are living with various forms of SCI, equating to substantial individual and societal burden (1). Acute traumatic SCI average costs alone range from $380K to $1.4M. This high socioeconomic impact has undergone significant inflation with estimated annual costs of $4 billion in 1990, recently increasing to $23 billion. Approximately 13,000 new traumatic SCI events are noted yearly in North America. Degenerative cervical myelopathy (DCM) represents the most prevalent etiology of nontraumatic spinal cord (ntSCI) and dysfunction in adults. The prevalence of ntSCI is order(s) of magnitude higher than that of tSCI.
Together, these conditions significantly impact millions of North Americans often with greater personal impact that chronic conditions such as diabetes or cardiac disease. The considerable societal concern due to this individual disability is compounded by the lack of viable treatment options.
DCM arises from age-related degenerative processes, leading to osteophyte development, facet joint enlargement, ossification of spinal ligaments, and disk protrusion. These arthritic changes collectively compress the spinal cord causing injury with associated ischemia and inflammation. In turn, a similar constellation of symptoms develop including extremity pain, reduced motor function, numbness, hemodynamic lability, urinary incontinence, bowel dysfunction, and walking instability contributing towards higher years lived with disability (DALYs) as well as overall economic burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: = 18 years and = 80 years.
- •Written informed consent by patient and/or legal authorized representative (LAR).
- •No other life-threatening condition.
- •No evidence of sepsis.
- •No evidence of superficial skin infection at site of surgery and intervention.
- •An established diagnosis of either:
- •cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or
- •acute cervical / thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T
- •The ability to undergo, or have had, surgical intervention. -. The ability to undergo transcutaneous intervention including study procedures in the posterior cervical or thoracic midline at or after 14 days from surgery.
排除标准
- •Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not limited to traumatic or disease conditions like brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, and Parkinson's disease.
- •mJOA of >= 15 and <= 7, or AIS grade E tSCI at baseline assessment.
- •Currently involved in another non-observational ntSCI or tSCI study, or receiving another interventional drug, that could interfere with recordings and confound adverse events.
- •Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and/or principal investigator.
- •Unable to commit to the follow-up schedule.
- •Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study.
- •Any condition likely to result in the patient's death within the next 12 months.
- •Prisoner.
- •Pregnancy.
- •Cardiac pacemaker dependent, unable to undergo electrical stimulation.
- •Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation.
- •Tattoo at site of skin electrode that causes heat/pain during stimulation.
- •Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.
研究组 & 干预措施
Non-Traumatic Spinal Cord Injury (ntSCI,) DCM - Progressive
Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy (DCM) and offered surgical intervention. Prospective.
干预措施: Transcutaneous Spinal Cord Stimulation (Tc-SCS) (Device)
Traumatic Spinal Cord Injury (tSCI) - Early/Acute
Traumatic spinal cord injury (tSCI) screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 2-6 weeks after injury.
干预措施: Transcutaneous Spinal Cord Stimulation (Tc-SCS) (Device)
Traumatic Spinal Cord Injury (tSCI) - Chronic
Delayed traumatic spinal cord injury (tSCI) screened 6-24 months after acute cervical/thoracic spinal injury. The use of transcutaneous spinal cord stimulation (Tc-SCS) in chronic SCI delivered in the delayed timeframe is relatively well studied, and therefore will serve as the control arm.
干预措施: Transcutaneous Spinal Cord Stimulation (Tc-SCS) (Device)
结局指标
主要结局
Blood Pressure
时间窗: Perioperative
Systolic and diastolic. Measured in mmHg
Lower Extremity: 10 Meter Walk Test
时间窗: Twelve Months
The participant is instructed to walk as fast and accurately as possible across a 10- meter length of hallway, without adaptive devices. This can be consistently recorded whether starting at rest or when already walking 'at speed'. Measured in seconds.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
时间窗: Twelve Months
An empirically validated and open worksheet for evaluation of sensation from C2 to S4-5, and motor strength of all major limb myotomes from C5-T1 and L2-S1. This determines the neurologic level of injury (NLI) and severity of motor and sensory completeness, with sensorimotor complete, sensory incomplete, motor incomplete without anti-gravity strength, motor incomplete with anti-gravity strength, and no significant deficit.
ASIA Impairment Scale (ASIA / AIS)
时间窗: Twelve Months
The product of the ISNCSCI examination includes a standard motor score (0-5) in five muscle groups in upper and lower extremity bilaterally with total extremity motor score of 100 (5 x \[5 upper + 5 lower\] x 2).
Modified Japanese Orthopaedic Association (mJOA)
时间窗: Perioperative
Validated in cervical myelopathy, the mJOA scale is a patient reported functional scale with 18 points assessing four domains, including: upper extremity (0 - 7), lower extremity (0-7), sensory (0-3), and micturition (0-3). This scale is further divided into severe (\</=11), moderate (12-14), and mild (\>/=15), with scores \<8 reflecting inability to perform clinical assessments (and are excluded).
Orthostatic Blood Pressure
时间窗: Perioperative
As defined by a sustained reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg within three minutes of standing after being supine for five minutes.
Post-Void Residual
时间窗: Perioperative
Defined as the amount of urine remaining in the bladder following urination. Measured in milliliters.
Upper Extremity: Grip Strength
时间窗: Twelve Months
Dynamometry measuring grip strength of both hands with participant directed to squeeze a force gauge between their thumb base and fingers at the distal interphalangeal joint. Average of three attempts, measured in kg of force.
GAITRite Walking Assessment
时间窗: Twelve Months
Quantitative analysis of gait using an electronic pressure mat, measured with gait stability ratio (single stance time / double stance time). Measured in time (seconds) and distance (centimeters).
WHOQOL-BREF
时间窗: Twelve Months
A questionnaire validated in, but not specific to, people with SCI. The WHOQOL-BREF been found to have excellent reliability, adequate-to-excellent validity with complete and incomplete SCI, and acceptable ceiling or floor effects. Measured as a raw score and converted to a percentage with higher values indicating a more positive result.
GRASSP
时间窗: Twelve Months
Gross and fine motor function of the hand is tested with subcomponents while manipulating common, but standardized, objects including jar and water bottle opening, grasping of key, coin, nut and bolt, and nine-peg test. Measured in time (seconds) to completion and/or percentage of completion in a given time period.
SCIM-vIII (PROM)
时间窗: Twelve Months
self-reported questionnaire comprised of 19 questions on daily tasks with a total score between 0 and 100 and subscales for self-care, respiration \& sphincter management, and mobility.
次要结局
- Adverse Event Rate(Twelve Months)
- Adherence to Protocol(Twelve Months)
- Serious Adverse Event Rate(Twelve Months)
- Data Collection and Monitoring(Twelve Months)
研究者
Francis Farhadi
Associate Professor, Neurosurgery
University of Kentucky