Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Occurrence of Adverse Events and Serious Adverse Events that are deemed related or possibly related to the study procedure or to the study investigational system, from implant surgery until the end of study.
研究概览
简要总结
The purpose of this study is to stimulate the circuits in the spinal cord that are directly responsible for hemodynamic control to restore hemodynamic stability in patients with chronic cervical or high-thoracic spinal cord injury. The ultimate objective of this feasibility study is to provide preliminary safety and efficacy measures on the ability of the hemodynamic Targeted Epidural Spinal Stimulation (TESS) to ensure the long-term management of hemodynamic instability and reduce the incidence and severity of orthostatic hypotension and autonomic dysreflexia episodes in humans with chronic cervical or high-thoracic spinal cord injury. In addition, the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, spasticity, trunk stability and quality of life in patients with chronic spinal cord injury will be evaluated.
详细描述
The investigators hypothesize that Targeted Epidural Spinal Stimulation (TESS) foreshadows a new era in the hemodynamic management of both acute and chronic SCI. It is envisioned that TESS will become the first-line treatment for hemodynamic instability in people with chronic SCI, where vasopressor agents and compression garments will become second-line treatments behind the precise control of blood pressure achieved with TESS.
In this study, the investigators propose to investigate the preliminary safety of hemodynamic TESS to modulate pressor responses and manage blood pressure instability in 4 patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension.
The study intervention consists of 8 phases preceded by pre-screening:
- Screening and enrolment
- Baseline and pre-implantation assessments
- Surgery
- Intensive TESS Configuration phase
- Daily supervised at-home TESS phase
- Long-term at-home phase
- Configuration of additional TESS programs phase
- End of study
Measures will be performed before surgical intervention and at regular intervals during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age 18 to 70 years old
- •Able to undergo the informed consent/assent process
- •Radiologically confirmed spinal cord injury
- •Spinal cord injury between C3 and T6
- •Classified with AIS A or B Spinal cord injury
- •Stable medical, physical and psychological condition as considered by Investigators
- •Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
- •Confirmed orthostatic hypotension and autonomic dysreflexia
- •Willing to attend all scheduled appointments
排除标准
- •Patients in an emergency situation
- •Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- •The inability to withhold antiplatelet/anticoagulation agents perioperatively
- •History of myocardial infarction or cerebrovascular event
- •Other conditions that would make the subject unable to participate in testing in the judgment of the investigators
- •Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the investigators
- •Clinically significant mental illness in the judgment of the investigators
- •Botulinum toxin injections in the previous 6 months
- •Presence of significant pressure ulcers
- •Recurrent urinary tract infection refractory to antibiotics
- •Current pregnancy
- •Current breastfeeding
- •Known or suspected drug or alcohol abuse
- •Unhealed spinal fractures
- •Presence of indwelling baclofen or insulin pump
结局指标
主要结局
Occurrence of Adverse Events and Serious Adverse Events that are deemed related or possibly related to the study procedure or to the study investigational system, from implant surgery until the end of study.
时间窗: From implantation through study completion, an average of 7 months
Investigate the preliminary safety of hemodynamic targeted epidural spinal stimulation (TESS) to modulate pressor responses and manage blood pressure instability in patients with chronic SCI located between C3 and T6 and who suffer from severe orthostatic hypotension (n=4).
次要结局
- Quality of Life questionnaire WHOQOL-BREF(At baseline and monthly during the rehabilitation phase, an average of 7 months)
- ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)(At baseline and during the rehabilitation phase, an average of 7 months)
- Spasticity clinical exam using the Modified Ashworth Scale (MAS)(At baseline and during the rehabilitation phase, an average of 7 months)
- Orthostatic head-up tilt test(At baseline and during the rehabilitation phase, an average of 7 months)
- Autonomic Dysfunction Following Spinal cord injury (ADFSCI)(At baseline and monthly during the rehabilitation phase, an average of 7 months)
- Trunk stability(At baseline and during the rehabilitation phase, an average of 7 months)
- Completion of a Daily Stimulation Log (DSL) by the patient(From daily at-home supervised used until the end of the study, an average of 5 months)
- Spasticity isokinetic quantification(At baseline and during the rehabilitation phase, an average of 7 months)
- Respiratory function evaluation(At baseline and during the rehabilitation phase, an average of 7 months)
研究者
Jocelyne Bloch
Professor, Neurosurgeon
Centre Hospitalier Universitaire Vaudois