Multi Site Long-term Follow-up for Those With Experimental Epidural Stimulation After Severe Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Motor Control Assessments with stimulation
研究概览
简要总结
The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to:
- provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life
- provide additional sites for follow-up so that the financial burden can be minimized for the research participants to travel
- collect long-term safety data; and
- when feasible collect data to understand the sustainability of outcomes.
Participants will:
- receive stimulation programs and software for the activities and/or functions completed in the previous study and demonstrate to the research staff that I can conduct them without their help to use at home
- continue using the stimulation programs at home as directed by the research staff
- return to Kessler Foundation for a follow-up visit (approx. 2 hours) with assessments at 6 months, 1 year, and once a year after enrolled in the follow-up study last until either the device is turned off, removed or the device is commercially approved.
详细描述
SCI participants who previously had an epidural stimulation device and completed the initial study can continue using stimulation programs at home once they have proven to study staff that they can use the programs and device on their own. This follow-up study will give insight into potential benefits from long-term use of spinal stimulation.
In-person follow-up visits (approx. 2 hours long) will be requested at 6-months, 1 year, and once a year until the device is removed or approved for commercial use. If the participant can't come to Kessler for an in-person visit, a remote tele-health visit will be arranged. Visits include:
-
medical history since the last visit will be collected
-
a physical exam
-
assessments completed during the study previously enrolled in including:
-
Testing of muscle and limb responses to stimulation
-
Assessment of sitting, standing, and stepping function
-
Bladder and bowel function tests
-
Spasticity assessments
-
Blood pressure monitoring
-
Questionnaires
-
MRI
-
TMS
-
DXA
-
The study physician will contribute to decisions about which of these assessments are most appropriate to perform at a particular visit
-
The investigators will review stimulation logs
-
The investigator will review results of the assessments and discuss continuing in the follow up 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •have a spinal cord injury that is not getting worse
- •received a neurostimulator and electrode array as part of a previous study
- •choose to continue epidural stimulation in the home and community
- •have completed a previous IRB approved epidural stimulation study at a participating research site
排除标准
- •heart, lung, bladder, kidney or other untreated medical disorder unrelated to SCI
- •choose not to use the epidural stimulation as recommended by the investigators
- •withdrawn from the main epidural stimulation study or made the choice to remove the stimulator/return the controller to the site
- •new surgeries, diagnoses, or other changes in status since completion of main epidural study that may affect the ability to complete assessments
- •Unable to undergo an MRI
- •Conditions that may make me ineligible for transcranial magnetic stimulation (a kind of brain stimulation through the skin)
研究组 & 干预措施
Home Use and Follow-Up Visit Group
Participants will be cleared by study staff for home-use of the stimulation programs they received in the previous study. Participants will then follow and log the programs according to study staff recommendations.
干预措施: Epidural Stimulation Programs (Device)
结局指标
主要结局
Motor Control Assessments with stimulation
时间窗: On average, 1 hour each visit completed 6 months, 1 year, and yearly
Participants will receive epidural stimulation and motor tasks based on their prior study participations' assessments and programming. During this stimulation, participants will be given motor tasks that may involve sitting, standing, stepping, and movement of their extremities. Electrodes will be placed over the specific muscles measured in that motor task. Data from those electrode readings will be transferred to numerical data. Plots from that numerical data will be created by identifying amplitude against stimulation intensity and threshold intensity, rate of recruitment, and plateau intensity per muscle using customized MATLAB software and then compared to results in the participants' prior training study.
Bladder Function Assessment
时间窗: on average, 30 minutes each visit completed 6 months, 1 year, and yearly
This assessment will only be performed in the participants who previously completed the locomotor, bladder and bowel intervention study (R-1230-23) The bladder function assessment includes a urinalysis and bladder pressure test. The bladder pressure test involves emptying of the bladder and refilling with saline with a catheter that measures bladder pressure. Urinalysis is to screen for bacteria. Results will be recorded and compared with previous study data.
Cardiovascular Assessment
时间窗: 24 hours prior to visit, completed 6 months, 1 year, and yearly
Participant blood pressure will be monitored over a 24-hour period outside the lab with a blood pressure monitor provided by the lab and during visit assessments. The reading will be recorded and compared to prior study readings.
次要结局
- Questionnaires(On average, 30 minutes each visit completed 6 months, 1 year, and yearly)
- Imaging Assessments(On Average, 15 minutes each visit completed 6 months, 1 year, and yearly)
- Spasticity Monitoring(Each visit completed 6 months, 1 year, and yearly)
研究者
Gail Forrest
Director, Tim and Caroline Reynolds Center for Spinal Stimulation
Kessler Foundation