The Feasibility of Epidural Electrical Stimulation (EES) for Improving Pain and Rehabilitation Outcomes in Patients With Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Multidimensional Pain Inventory (MPI)-SCI average activity score
研究概览
简要总结
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 24 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy.
Participating subjects will be allocated to one of two treatment groups:
- Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation.
- Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation).
For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm.
At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 24 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
详细描述
This study is a prospective, single center study. Data will be collected at baseline, time of procedure (trial and permanent), trial phase, and at 1, 3, 6, 12, 18, and 24 months post-implantation.
The primary objective of this study is to to determine if neuromodulation can be used to augment pain relief and rehabilitation in spinal cord injury (SCI) in a real-world population while further characterizing neurophysiological measures and clinical outcomes.
The following data will be collected:
- Medical history and demographics
- Procedure characteristics
- Medications
- Visual Analog Scale (VAS) for pain intensity Guy/Farrar Patient Global Impression of Change (PGIC) scale ASIA motor and sensory scores and impairment grade
- QoL survey (PROMIS 29)
- Electromyography (EMG) / Nerve Conduction Studies (NCS)
- Spinal Cord Independence Measure (SCIM) survey
- Bladder control using standard clinical urodynamic studies
- For sleep, self-reported quality and average hours per night will be collected in a diary
- Programming parameters and characteristics
- Safety events (adverse events, device deficiencies, protocol deviations)
The outcome variables of interest will be collected and assessed across study visits. No pre-planned formal statistical hypothesis tests will be performed. Multivariable regression modeling and descriptive statistics will be utilized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):
- •Traumatic, thoracic SCI
- •Chronic neuropathic pain (i.e., Pain >3 for > 3 months)
- •Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
- •18-80 years of age
- •Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens
排除标准
- •Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):
- •Complete cord transection
- •Persistent spinal instability or other injury preventing ability to participate
- •Active infection
- •Comorbid psychosis or psychotic disorder
- •Untreated, clinically significant depression
- •Active drug or alcohol abuse
- •Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test
- •Patients without symptoms of neuropathic pain >3/10 for > 3 months
- •Patient deemed not medically stable for surgery
研究组 & 干预措施
EES on
Patients will undergo epidural electrical stimulation (EES) and be allocated 1:1 to EES on.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments.
干预措施: EES on (Device)
EES off
Patients will undergo epidural electrical stimulation (EES) and allocated 1:1 to EES off.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Those in the EES off category will have their EES turned on at the 9-month time point.
干预措施: EES off (Device)
结局指标
主要结局
Change in Multidimensional Pain Inventory (MPI)-SCI average activity score
时间窗: Baseline, 3 months
The MPI-SCI consists of twelve 7-point subscales in three sections: (1) pain impact, (2) responses by significant others, and (3) activity. Our primary outcome is the average score of the 4 pain subscales (household activities, activities away from home, social activities, and outdoor work) for pain and consequences of SCI. These 4 scales are commonly used to create a single general activity scale. To define the degree to which pain and other consequences of injury reduced participation in a specific activity, 2 additional validated items will be used in section 3: (1) "Pain has reduced my participation in this activity," and (2) "Other consequences of SCI have reduced my participation in this activity." The response range from 0 (not at all) to 6 (extremely).
Change in Multidimensional Pain Inventory (MPI)-SCI average activity score
时间窗: Baseline, 3 months
The MPI-SCI consists of twelve 7-point subscales in three sections: (1) pain impact, (2) responses by significant others, and (3) activity. Our primary outcome is the average score of the 4 pain subscales (household activities, activities away from home, social activities, and outdoor work) for pain and consequences of SCI. These 4 scales are commonly used to create a single general activity scale. To define the degree to which pain and other consequences of injury reduced participation in a specific activity, 2 additional validated items will be used in section 3: (1) "Pain has reduced my participation in this activity," and (2) "Other consequences of SCI have reduced my participation in this activity." The response range from 0 (not at all) to 6 (extremely).
次要结局
- Change in pain as measured by Visual Analog Scales (VAS)(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in the overall improvement as measured by Guy/Farrar Patient Global Impression of Change (PGIC) scale(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by the ASIA impairment grades(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in independence of activities of daily living (ADLs) as measured by the Spinal Cord Independence Measure (SCIM) survey(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in bladder control using urodynamics(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS MEPs)(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by EMG(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by the ASIA impairment grades(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in independence of activities of daily living (ADLs) as measured by the Spinal Cord Independence Measure (SCIM) survey(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in bladder control using urodynamics(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS MEPs)(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by EMG(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in pain as measured by Visual Analog Scales (VAS)(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in the overall improvement as measured by Guy/Farrar Patient Global Impression of Change (PGIC) scale(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
- Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score(Baseline, and then months 1, 3, 6, 9, 12, 18 and 24)
研究者
Nandan Lad, M.D., Ph.D.
Professor of Neurosurgery
Duke University